Welcome to the HFSA Amended Heart Patient Education Webinar. I am Susan Ammon, and I'm the Senior Project Manager for the HFSA Research Network. We would like today's webinar to be interactive, and as such, we encourage you to submit questions to our presenter using the questions tab on the left side of your screen. Please feel free to submit your questions at any time. The question and answer portion of the program will immediately follow the presentation. We'd also like to point out a great feature for those who wish to take notes during the presentation. When you click on the notes tab on the right side of the screen, you will see a white text box where you can take notes on today's webinar. These notes will be emailed to you automatically at the end of the presentation. So our speaker today is Dr. Richard Patton. Dr. Patton received his medical degree from the University of Maryland School of Medicine, where he completed a medicine internship and residency, along with an added year of clinical heart failure research. He completed his cardiology training at Tufts Medical Center in Boston in 1995, where he remained on staff through 2008, during which time he served as Associate Medical Director of the Heart Failure Cardiac Transplant Program. He was also an NIH-funded investigator within the Molecular Cardiology Research Institute at Tufts, exploring the mechanisms by which estrogen and its receptors influence myocardiobiology. In 2008, he joined the New England Heart Institute in Manchester, New Hampshire, where he helped develop the Advanced Heart Failure and Cardiomyopathy Service and launched a mechanical assist device program. In 2014, he began work at Lahey Hospital and Medical Center in Burlington, Massachusetts, where he directs the Lahey Health Integrated Heart Failure Network, whose aim is to bring high-quality heart failure care to Lahey Hospital and its affiliates. Dr. Patton is board-certified in cardiovascular disease and advanced heart failure and transplant cardiology. He has a particular interest in diagnosing and managing patients with heart failure and cardiomyopathy at any stage. His research interests include characterizing left bundle branch block-associated cardiomyopathy, and he's also a co-investigator on a funded study establishing an imaging and biomarker registry of patients with cardiac sarcoids. So let's get started. Dr. Patton? Susan, thank you for that kind introduction. My name is Rick Patton, and I'm here today to present this patient-centered tutorial covering the topic of clinical trials. Heart failure is prevalent in our society, and its incidence is likely to rise in the coming years. Patients with heart failure are therefore increasingly likely to be approached about participating in a clinical trial. It is therefore important to realize that all of what we know today regarding the management of heart failure has resulted from medical scientists and from patients like you who are willing to participate in these studies that benefits generations to come. This is the outline of my presentation today. We'll first cover important terms and definitions, followed by a discussion of the types of clinical trials. We will then discuss potential benefits, risks of participating in a clinical trial, while also addressing possible safety concerns. This tutorial will end with some questions, some important questions to ask when considering participating in a clinical trial. I'd then be happy to stay and answer any questions from the listeners today. Well, what is a clinical trial? A clinical trial is a research study with a specific purpose. For example, a research study may seek to collect information about people with a specific disease to gain more knowledge about that condition. A research study may also explore whether a particular treatment can offer some benefit, such as helping patients feel better or live longer. Realize that the information gained from clinical trials forms the basis for much of our understanding of diseases and how best to treat them. These are some important terms to know. The investigator is a medical provider who is in charge of a study at a given hospital or institution. A subject is a person who has agreed to participate in a clinical trial. The treatment group is that group which receives the new treatment being explored, often in addition to standard therapy or compared with standard treatment. The control or placebo group is that which receives standard therapy only to serve as a comparison to the treatment group. Most trials randomly choose which person will be placed into the treatment group or the control group. In the next slides, we will discuss the various types of clinical trials. The first we'll discuss are observational studies. Observational studies may have one of several purposes. Often times, they will attempt to define the course of a given disease by gathering relevant information on individuals who agree or consent to participate. Such observational studies are also known as registries and may explore how a given variable such as gender or race influences the course or outcome of a given disease. Variable information such as age, gender, race, height, weight, or even results from routine blood tests is collected and the course of patients is followed over time. The OPTIMIZE-HF study offers one important example of an observational trial or registry. OPTIMIZE-HF was a heart failure registry that collected data on patients hospitalized with heart failure from March of 2003 through the end of 2004. The registry enrolled over 48,000 patients hospitalized for acute heart failure at 259 centers in the United States. During this trial, important individual data was collected and compiled. In the end, this study helped investigators understand how certain patients with heart failure were treated and how providers might improve their treatment approaches. This bar graph outlines some of the treatment information obtained from OPTIMIZE-HF. These investigators, led by Dr. Greg Fonaro, reported on the types of treatments and interventions that patients with heart failure received. They specifically looked at patients with heart failure caused by left ventricular systolic dysfunction, also known as heart failure with a reduced ejection fraction. Data from these patients is shown in the green bar graphs. They compared this group to patients with preserved systolic function, abbreviated PSF, and also known as preserved ejection fraction. These data, which are shown in the blue bar graphs, represent this group. They found that the vast majority of patients with systolic dysfunction, or LVSD, were appropriately treated with medications known to benefit this condition, such as ACE inhibitors or angiotensin receptor blockers and beta blockers. However, they reported that aldosterone antagonist use, aldosterone antagonists are another group of medications shown to have significant benefit, were vastly underutilized. This was one of several important findings from this registry. I now would like to shift gears a bit and discuss another major subgroup of clinical trials known as therapeutic trials. We study the impact of an intervention on a specific condition. An intervention might include, for example, implantation of a device, such as a pacemaker. A therapeutic intervention might also include a new type of medication or even non-medical treatment, such as, for instance, an exercise program, dietary changes, or disease-specific teaching. There are several types of therapeutic trials. We'll start by discussing open-label versus randomized trials. Open-label trials are those in which all participants receive the treatment under investigation in an open-label manner. This means that both the subject and the investigator know that the participant is receiving the specific therapy being studied. This approach does have advantages. For example, safety can be assessed. In the case of a medication, the best effective dose may be determined. There are also disadvantages, however. First and foremost, the conclusions that can be drawn from open-label trials are very limited because there is no direct comparator or control group. In this case, it will therefore be unclear whether this new treatment offers any true benefit for the condition being studied. Another important subtype of therapeutic trials are randomized trials in which subjects are randomly assigned to be included in the control group or the treatment group. Remember, the control group is that group of patients which receives standard therapy. It serves as an important comparator group. This is required to see if a new treatment or intervention helps, has no effect, or makes patients worse. When a medication is being investigated, this group will oftentimes receive a placebo, which is a pill made up of inner material, sometimes referred to as a sugar pill, in place of the actual medical treatment being studied. Within a randomized trial, the treatment group receives the actual intervention or medication being studied in place of or in addition to standard therapy. Within randomized trials, there are single blind studies in which the participant does not know or is blinded as to whether they are receiving the real treatment or not. This is important because sometimes control group patients will feel better simply because they expect to. This is also known as the placebo effect. However, there is an opportunity in a single blind study for a bias because the investigator knows which treatment the subject is receiving. Bias on the part of the investigator may interfere with the trial results. The best type of randomized trial are therefore double blind studies. In these studies, neither the subject nor the investigator know what treatment, either real therapy or placebo, the subject is receiving. These are considered the most scientifically rigorous types of trials. They reduce the likelihood of bias, that is, the treatment is concluded to be helpful because that is the expected result. Such studies are required by the FDA before a drug or device is approved for a specific condition. This slide presents an example of a key clinical trial in heart failure. SOLVED stands for Studies of Left Ventricular Dysfunction. The SOLVED treatment trial analyzed the effect of the ACE inhibitor, enalopril, given to patients with heart failure and a reduced ejection fraction, or left ventricular systolic dysfunction. The SOLVED trial found that treatment with enalopril led to a 16% reduction in all-cause mortality after slightly more than three years of mean follow-up time. I can't emphasize enough the importance of this trial that formed the basis for one of the most important treatments in heart failure. Moreover, from the observations conducted within the SOLVED trial, great insight was obtained as to why the heart failure syndrome may progress over time. These observations, and others, led to further treatments that are now the standard of care. This knowledge would not have been possible without the willingness of patients like you to participate in this landmark study. Well, what are the benefits of participating in a clinical trial? There are numerous benefits, some of which are listed here. First, you will be contributing to advances in a specific field. In addition, what we learn from almost any trial may help future patients with the same condition do better. You will be cared for by providers who are experts in a given field, such as a heart failure specialist. Usually the control or placebo group in a given trial does surprisingly better than what is anticipated. This is thought to result from improved care while participating in a clinical study. The cost of medications is usually covered, and in some cases, participants may be compensated for their time and participation in the study. What are the risks of participating in a clinical trial? For one, the new therapy may not offer any advantage over standard treatment. And although not likely, a new therapy may tend to worsen patient's condition or survival. This effect is usually subtle and not dramatic. And how are clinical trials kept safe? In any therapeutic trial, there is an entity known as the Data Safety Monitoring Board, or DSMB. This is a committee that meets every three to six months to review information about the patients treated with the new therapy versus those in the control group. If the Data Safety Monitoring Board feels as though the study treatment offers overwhelming benefit, they may halt the trial early to report the results in order to speed the approval of that new therapy. If the DSMB observes that the new treatment may be causing harm, they may choose to stop the trial prematurely in order to study this information more fully. When considering participating in a trial, always address questions of safety to the investigator or a representative. When considering being a subject in a trial, you will have to review and sign a form known as the Informed Consent Form. This is a document that the investigator will give you to review. It covers information regarding the trial, risks and benefits, techniques, medications, therapy and visits that are involved in participating in the trial. You should read this document carefully and then make the decision if you wish to participate. Reviewing this document will give you the opportunity to consider all important questions regarding the trial. Well what are important questions to ask when considering being a subject in a trial? Here are some to consider. Why do the researchers believe the new treatment might be helpful? Has it been tested before? How is it determined which interventions I receive, for example, by chance or randomly? Will I know which intervention I receive during the trial, i.e., am I blinded as to which treatment I am receiving? What are the possible risks, side effects and benefits of this trial compared with those of my current standard treatment? Will I be paid for my participation? Will I be reimbursed for expenses? If I benefit from the new treatment, can I continue receiving it after the trial ends? Will results of the study be provided to me? And what are my options if I am injured during the study? More information resources for clinical trials can be found at the website clinicaltrials.gov. This site offers both general information and specific material for all active and completed clinical trials. The Heart Failure Society of America also offers educational resources to patients and families. Please visit our website to learn more about educational materials and our Heart Failure Patient App, Heart Failure Health Storylines. These can be found at www.hfsa.org. This community education program is made possible through support by Amgen and Cytokinetics. I'd like to thank everyone for their attention today, and again, I'm happy to stay and answer any questions that have come up. Well, thank you, Dr. Patton. That was one of the most thorough review of clinical trials I've ever seen, so thank you very, very much. Now, if you have a question, participants can submit it in the questions tab. And before we begin, I'll also mention, as Dr. Patton said, that there are 11 heart failure education modules designed to help patients learn to live successfully with heart failure, and they can be found on our website. In addition, all of the other recent patient webinars have been recorded and can also be found on our website as well. Feel free to view the webinars yourself or share the link with friends and family. And last but not least, I wanted to say that the HFSA Research Network is developing a section on the HFSA website to list clinical trials and heart failure for patients, providers, and investigators to learn about current trials to see if they may be interested in participating. There'll be more to come as that develops. I don't see any questions coming up yet, so please, I'm sure that there's some out there. Go ahead and put them in the questions tab and we'll ask them. And while we're waiting, you know, Dr. Patton, as you mentioned in the very beginning and also throughout, patients are so important to the success of clinical trials. In your experience, what do you think is the most common reason why people agree to be in a trial, and what's the most common reason why they decline? I would say the most common reason for agreement is having already a trusted relationship with their provider. And if that provider either recommends a trial or is actually an investigator within the trial, I would say that it's that provider-patient relationship and that trust that's been established that is probably the primary reason. And also those seeking to maybe benefit their condition. I would also say that many patients take it upon themselves to participate merely to advance our knowledge of the disease and how best to treat it. So I think there's also a good bit of altruism involved. I think patients may avoid specific trials for fear of very new treatments. I would add that most trials are those which are conducted beyond a Phase I study, which is the initial safety study. So most of the time, a given treatment has at least been shown to be safe at the current doses that are being evaluated, at least when it comes to medical therapy. But I think there are some people out there that are simply, they simply fear new therapies. And I think also when participating in a clinical trial, there can be frequent visits and that may offer a significant time challenge to some patients. Thank you. You know, there is a question that pops up here that sort of feeds into that first question. How if a patient is willing and wanting to find out about trials, how would you recommend that they can find out and find out what trials are being currently investigated? Well, I think probably the most comprehensive resource will be the clinicaltrials.gov website. On this site, you can find recent and active clinical trials and even listed within a specific trial. You can determine if any centers in your area are participating. And on the clinicaltrials.gov website, they have a very handy search engine whereby you can simply enter a key word such as heart failure or heart failure trial. And they will then give you a list of all the active clinical trials that are ongoing. I think I have often gone to clinicaltrials.gov and they do try to keep it updated as much as possible and it's a great resource. I would like to say again that the Heart Failure Research Network, we are planning on putting it on our HFSA website so that we can have patients review what trials are available and we're hoping to even write it into, you know, language that's a little bit more understandable for patients that may not be involved in research. I would add that another resource can be your provider. Meaning, if a given person is interested in exploring what clinical trials might be available, they could also ask their provider what their knowledge might be in this regard, and if not, whether they would be willing to do a little background research. I think that's an excellent suggestion. Is there another question up here? Give me a moment to review it. A participant is saying that they would like to participate in a trial which addresses the cause of my heart failure, and not merely managing the symptoms. Are there any such trials that they could find that would address that question? That's an excellent question. And I think oftentimes in trials that are testing new therapies, there are sort of sub-trials within a larger trial. These are called sub-studies. And many sub-studies within a broad clinical trial are directly geared at that very point, meaning not just attempting to improve symptoms, but attempting to identify further causes of heart failure. For example, in the modern era, many trials will ask for additional blood from patients so that they can do gene sequencing that may offer insight as to which genetic markers or variances or mutations might increase the likelihood of a given disease. And that's just one example of where a therapeutic trial may have a sub-study to explore further certain causes or at least associations. All right, thank you. I have another question for you, Dr. Patton. The ACC Digest reported today that women and older adults are not appropriately represented in clinical trials for heart failure. Women generally only make up 30% of the participants when nearly 50% of the heart failure population are women. I'd like to hear your thoughts about this and what we can potentially do to correct it. I guess I would say that as an investigator, we now fully realize the fact that women and minorities are underrepresented in clinical trials. Some of that is demographics, at least when it comes to minorities and where you practice. But you're exactly right on the underrepresentation of women. NIH will oftentimes have strict guidelines about clinical trials that they are willing to fund and now require that women and minorities be sufficiently represented in trials. So I think that wave is changing, though I'll also admit I think it's changing very slowly. But hopefully we'll improve in the future. Okay. I guess more of a comment. I remember when I was actively involved in recruiting patients for trials, I found that many patients were fearful or they had ideas that didn't seem to really be what we were trying to do. And I was wondering, what do you think is the most misconception that you hear about clinical trials? I think the most common misconception is, and I hear this with some frequency, is that people don't want to be guinea pigs, meaning they don't want to feel as though they're being experimented upon. And I guess I would say I can fully understand that mindset and that fear. But I would just reinforce that every trial has specific safety measures included to maximize the safety of all participants. And as an investigator, investigators and all providers that are participating in the trial are required to have a great deal of education with regard to the specific responsibilities of investigators and how important their responsibilities are, with the primary responsibility of any investigator being to keep patients and participants safe. I always like to say that research is good medicine because as you mentioned in your slides that you have a team that specializes in the area of research and it offers a lot of good care. When we are investigating a new drug, I often get questions about, well, are you going to take me off of my usual medicines just to put me on something that we don't know that can work, I guess that would be called the usual care versus treatment group. Could you explain a little bit more what that means to patients? Well, I think most heart failure trials are those in which medicines are added on top of standard therapy. And I think the benefit of that is if you participate in a trial, you will remain on standard therapy in addition to at least possibly a new treatment. I think the drawback of that approach is that the therapeutic library, if you will, continues to grow and then people get placed on more and more numbers of medications for a given condition. Which is one reason why I think the most recent, at least large-scale heart failure trial that tested the new drug Sacubitril Balsartan was attractive to me in that it actually tested the new drug versus an ACE inhibitor. And there are several reasons why that approach was appropriate and also necessary. But at least in that regard, we now have a new therapeutic approach that is in place of, and not necessarily in addition to, the important trio of medications for heart failure, at least that with a reduced ejection fraction. Yeah, I think that's a very good point. That's probably one of the more recent studies that actually did stop the usual care. But as you said, develop a trust with the investigator. What is the benefit that you think it's going to find? And in fact, we did find a benefit. A question came in that's saying, if you find a trial that you'd want to participate in, how do you sign up? I think that would be relatively straightforward. But it would involve identifying which center in your area is participating in the trial. And if so, it would be a matter of probably just calling that department number, such as the cardiology department main line, and ask to speak to at least a representative of the investigator at that center. And I think on clinicaltrials.gov, they do have the contact information. So that would be the first step there. And as you said before, maybe talking with your own primary care and getting their input as well. Yeah, I think, in my experience, a trusted provider and a good relationship between provider and patient is worth its weight in gold and is just so important. Well, Susan, I guess I'd like to add that I greatly look forward to the Heart Failure Society of America Research Network. And I'll look forward to learning more about that at the upcoming meeting. And of course, on the hfsa.org website. Yeah, we're pretty excited about it. We feel like, you know, being the Heart Failure Society of America, we have all of the specialists in heart failure and investigators that are there. And we'd like to be the leading force in that. We want to educate patients on how important it is to be in trials, what a trial is. And the tool that we're developing right now will, we hope will work a little bit better for patients than the clinicaltrials.gov, because that can be pretty sophisticated in a sense that, you know, it's hard to understand exactly what's going on. So we really want to make sure that we can reach out to the patients because you can't develop new treatments without the patient's participation. And so that's very, very important. We want to do education on the actual investigators and study coordinators, and it's really exciting. So I'm very, very thrilled to be part of that. And we will be having a paper come out from our survey that we did of over 500 investigators, study coordinators who are actively in research. So I hope to see you there as well. And that meeting that Dr. Patton's referring to is the annual scientific meeting of the Heart Fair Society of America that will be in mid-September in Nashville, Tennessee. So, great. Okay, here's a question. Does the clinical trial have to be in my area or can I participate remotely, as in can I have the treatment administered by a local hospital or do I have to travel? I think participating remotely would be difficult unless a given center has a relationship with a satellite institution that might be already joined with them as far as enrolling and conducting clinical trials. But I think most patients would have to be relatively near to the primary center in most clinical trials. Yeah, there's a lot of factors involved in being allowed to have a study at your institution. So there's a lot of IRB and safety and contracting, but there are some trials or some industry partners that are thinking of remotely virtual trials in the sense of registries, because we really do not have a registry that's really large and nationwide for those with heart failure, both preserved and reduced ejection fraction. And there, I would think that by calling in or doing virtual visits, there could be something like that available for patients. And again, I would look at the clinicaltrials.gov or on our website. We'll be looking for those things as well so that we can gain more information on real-world experience of people that have heart failure. So I think that that is coming up a lot more than before because they know that people can't travel and we wanna get more American patients into our studies. Well, Dr. Patton, I do have another question that from my experience in research, what patients would ask me is, as you said, we have a double-blind or a randomization process and a patient is given either the placebo, the sugar pill, or the active study medication. During the course of the trial, we're collecting lots of information about each of those groups. One question that I used to get a lot is that, well, if I stopped taking the study medication, why do you still collect data on me? Could you address that question? I think that has primarily to do with scientific rigor, meaning if someone enters a clinical trial, there is a concept known as intention to treat, meaning in the real world, when real patients are treated, sometimes they say, I wanna stop taking that medication. So I would suggest that because that occurs in the real world, in a clinical trial, those patients are still tracked and they are included in the outcomes to try to match as best as possible as to what might happen in a real-world setting. Here's a question. Are the participants tested regularly, given ECHOs, stress tests, et cetera, during the course of the trial? Yeah. Trials vary quite a bit in regards to that. And I guess, as I've addressed most of these questions, and as you just brought up, Susan, I haven't been referring that much to registry data. And for registries, these data are usually already available. But that being said, in therapeutic trials, some therapeutic trials will have specific endpoints that require serial echocardiograms, or serial stress tests to assess exercise time or exercise capacity. But some trials are geared only towards more clinical endpoints, such as being hospitalized for heart failure, for example, or such as requiring up titration of diuretic medications. So it really depends on the endpoints of the trial and what else is being explored. Well, that brings me to my next question. Can you describe to our audience what is an endpoint? An endpoint is, but that's a good question. I didn't even cover that. An endpoint is a given outcome of interest in a study. So that endpoint might be how many times a given person is hospitalized for heart failure or another cardiac issue over the three years, for example, of a clinical trial. So whether there are any hospitalizations, and if so, how many, may be an important endpoint of a clinical trial. Death is an important endpoint of many clinical trials. Other trials, referring back to the question, might have an endpoint that includes echocardiographic variables, such as the size of the left ventricle and whether that chamber is dilated, and if so, how much. So these are endpoints that may be the focus of the analysis at the end of a study, at least examples of those. And I find that in determining what the endpoints for the study are going to be, there's more and more emphasis on patient participation in that decision-making. Would you agree with that, that we want to know what patients want to find out from a particular study? Absolutely. And I think along those same lines, quality of life can be assessed in various ways. And as we've seen over the past 10 years, there's been a great increase in quality of life assessments in almost any area of clinical research. And another thing that the Heart Care Society of America is looking into is having a patient partnership, not only just to help guide the society in meeting the needs of providers and patients, but also in research trials. So it's a very big deal now. So the patient should really feel empowered, and we hope that they will become more active participants. Well, I serve on the Education Committee in the HFSA, and one of my great loves of that committee, in all seriousness, is the patient-centered tutorials, like this one today, like the many pamphlets we've devised, and many of the presentations that are given both during the annual scientific sessions and even apart from that, oftentimes in conjunction with Mended Hearts, which I would just like to emphasize is another great patient advocacy organization. Yeah. Here's a question. Are all clinical trials drug-related, or are there procedure-focused studies that I can participate in? Well, some trials will look at specific procedures to see if they have merit or benefit. An example of this might be something such as a defibrillator, which are now a standard of care for at least many patients with a reduced ejection fraction. But some trials focus on other interventions, such as a supervised exercise program. It was a famous trial conducted several years ago called ACTIV-HF that simply explored the benefit of a supervised exercise program or cardiac rehab for patients with heart failure. And the results of that trial were very positive and encouraging. So not all trials look at medications. There are devices or other interventions, dietary interventions, and even teaching interventions. Yeah, I think, and they're generally all listed on clinicaltrials.gov as well. So that would be a good source if you are looking for something that's not drug-related. Here's a question. Is there any resource to better guide me in clinical trials as they've read many descriptions of them and didn't feel that it was fully understood or grasped if they qualify or not? And what the goals were of the trial. How would you lead a patient to find out more about that? Well, I think there are several ways to go about that. I think, first and foremost, I'd probably refer them to their provider, be it a primary care provider or a cardiology provider, to discuss questions surrounding a given trial. If that provider isn't knowledgeable in this regard, you could also contact the principal investigator or at least the local center that is participating to ask further questions. So I think that would probably be the best approach because seeing this information can sometimes be overwhelming and hard to understand. And I think having a direct conversation with a provider is probably the best advice I can give you. And there are so many inclusion-exclusion criteria that even the study team has trouble at times, but they would, in my experience, when a patient is interested in the trial, there's such a thorough backup check on all of the inclusion-exclusion criteria. And perhaps you might want to address what all those mean as well, Dr. Patton, for our group. Oh yeah, sure, thank you. Yeah, thank you for that. It's more of the willingness of wanting to participate and then people will look at the inclusion-exclusion, and I'll let you go ahead and answer that to explain that. Well, all trials have inclusion and exclusion criteria, and inclusion criteria for heart failure usually applies to at least adults with heart failure if it's focusing on the adult population. So age greater than 18 is an inclusion criteria that's common. And commonly, pregnant women are excluded from, or women that are planning on getting pregnant are oftentimes excluded because of the concern that a new therapy or intervention might affect their ability to either get pregnant or may affect their fetus or their child. So those are just sort of black and white examples of an inclusion and an exclusion criteria. Oftentimes, patients with advanced kidney disease, meaning those who are approaching dialysis, may be excluded from a clinical heart failure trial, sometimes because the medications can influence kidney function. So I think that addresses some of the inclusion and exclusion criteria. As an investigator, if I have any doubt or question, I'll just contact the principal investigator, oftentimes it's somebody that I know, and I'll either send an email and wait a day or just make a phone call to say, I have this person, they're interested. This is where I think there might be a glitch. What do you think? And that kind of direct communication between investigators I think really helps make sure that we're enrolling the appropriate people. And I think I would just add to that that you're enrolling people that the study will be safe. In my opinion, that's the exclusion criteria is something that really makes sure that we're going to do the best thing for the patient. Exactly right. Yeah, thank you for that. Exactly right. Do you have any final comments you'd like to add, Dr. Patton? I would just like to emphasize that clinical trials is how we move the science and our knowledge further and how we benefit generations to come. So if any of you out there are so inclined, I just strongly encourage you to participate if you can, because as providers and medical scientists, we greatly appreciate that input and that help. And I would just echo that too. We cannot do it without you. So I want to thank everybody for participating in today's webinar, especially when I think Dr. Patton, I thought it was a very thorough discussion of clinical trials. And let everyone know that a recording of this webinar and all the others can be found on the HFSA website at www.hfsa.org. Want to thank you and have a great day. Bye-bye. All right, thank you, Susan.

HFSA Amended Heart Patient Education

webinar

Susan Ammon

Dr. Richard Patton

clinical trials

observational studies

therapeutic trials

participation