What is the National Heart Institute?
We are a clinical research center with world-class physician investigators and clinical research coordinators working to find better treatments for a range of cardiovascular and metabolic disorders.
THE NATIONAL HEART INSTITUTE FAQS
The National Heart Institute offers clinical research trials to find new and better treatments to treat and prevent cardiovascular disease. Below are some frequently asked questions the answers to which will help you learn more about NHI, the trials, and your participation. Please contact us if you have additional questions not covered here.
Who is Dr. Norman Lepor, NHI’s Founder and Director?
Dr. Norman Lepor is a graduate of The Johns Hopkins University School of Medicine and double-boarded by the American Board of Internal Medicine for Internal Medicine and Cardiovascular Disease. He has been a Principal Investigator on over sixty clinical trials over the last twenty-five years, many of which have been published in the most prestigious peer-reviewed medical journals and have had a very positive impact on a variety of cardiovascular conditions. Dr. Lepor is joined by a group of physician sub-investigators who support the research efforts and are dedicated to improving the health of not just their patients but those around the world.
What does NHI’s coordinating staff do?
Our team is responsible for arranging patient research visits, gathering important background medical information on all research participants, assessing for adverse events and side effects, dispensing research medication, and ensuring that research protocols are adhered to under the direction of the physician investigators.
Why does NHI focus on cardiovascular disease?
Cardiovascular disease is the number one killer of Americans and a leader in causing disability. Most people have family or friends who have died of cardiovascular disease, suffered a heart attack or stroke, needed an amputation, or are dealing with hypertension, heart failure, arrhythmias, obesity, or diabetes. As healthcare professionals, it's critical that we find new and better treatments to treat and prevent cardiovascular disease. NHI is committed to that goal, and we have a record of getting results.
What is a clinical trial?
A clinical trial is a process to find better and safer treatments. NHI provides clinical trials for cardiovascular and metabolic diseases such as coronary artery disease, heart failure, cholesterol disorders, hypertension, arrhythmias, diabetes, chronic kidney disease, and obesity. These trials are approved by the United States Food and Drug Administration (FDA) and supervised by outside clinical research monitors and NHI investigators to help guarantee patient safety.
How are patients kept safe?
NHI’s staff are well versed in Good Clinical Practice concepts and the details of the protocol for each clinical trial. Every trial has its own approved protocol that defines the eligibility of a patient for a trial and the actual performance of each trial visit so that the trial is conducted consistently by clinical trial sites worldwide. We also carefully monitor the patient's condition, blood, and other test results that are performed per research protocol.
What are NHI's goals for clinical trials?
To assist in developing newer treatments that do a better job of treating these conditions so that patients can avoid complications such as sudden death, heart attack, stroke, heart failure, amputation, or dialysis.
Why participate in a clinical trial?
- To have access to high-quality care that compliments what they receive from their current healthcare professionals.
- To find better treatment for someone with a cardiovascular condition or who is at risk for one.
- To have access to the latest research developments that may positively impact a patient's care and quality of life.
Who should apply for NHI's clinical trials?
We are seeking patients who have health conditions that place them at risk of cardiovascular complications: coronary artery disease, cholesterol disorders, diabetes, heart failure, chronic kidney disease, obesity, and hypertension. Some of these patients may have failed conventional treatments and have suffered a heart attack, stroke, amputation, or needed to have a stent procedure or bypass surgery. We are also committed to reaching out to an underserved population, patients who would not otherwise be able to access this level of treatment. Patients can only participate in one clinical trial at a time.
What clinical trial is best for me?
At any given time, NHI has a variety of clinical trials that focus on heart failure, cholesterol abnormalities, diabetes, obesity, high blood pressure (hypertension), and chronic kidney disease. We also work with patients with a history of heart attack, stroke, and blockages in the arteries to the heart, brain, and lower extremities which may have undergone treatments such as angioplasty, stents, or bypass surgery.
How do I get matched to a trial?
NHI’s investigators work directly with patients and their physicians to discuss clinical trial options and match their specific cardiovascular problems with a trial best suited for them. Then they will explore if the patient meets the trial-specific inclusion and exclusion criterion.
Is anyone automatically excluded?
Generally, trials will exclude patients with a recent history of serious cancer within three years or other health condition that limits life expectancy and patients who are not compliant with their medications and trial visits or have a history of substance abuse. Each clinical trial has specific entry criteria that include a variety of demographics, including age, kidney and liver function, and the types of medication they are currently taking.
How do I apply to participate in a clinical trial?
First, fill out NHI’s patient clinical trial questionnaire with your important medical information. You may need to ask your treating healthcare professional to provide some of the information. We understand that you may not have all the answers to the questions, but the more complete you are with filling out this questionnaire, the better we will be able to determine if there is a clinical trial we can match you to. This information will be kept strictly confidential and consistent with HIPPA laws. Then you will state what trial you are interested in participating in. NHI’s staff will guide you to match your health condition to the available clinical trial considering your preference, a process we call shared decision-making.
Will I be sure to get into the trial I want?
Some trials may close to enrollment once goals are met, while new trials will open. It’s important to complete the clinical trial questionnaire as soon as possible, but we cannot guarantee that a particular clinical trial will be available at any given time. Your information will be kept in a database so that if you are not eligible for a current trial, we will try our best to match you to a new trial.
How long do NHI’s clinical trials last?
Depending on the type of clinical trial, they can last from 3 months to 3-5 years.
Will I be paid to participate in a clinical trial?
Though financial gain as an inducement to participate in a clinical trial is not recommended, most trials do allow for payment for study visits and cover the costs of parking. The payments are study specific, and you will be informed of what the payment will be at the time of the screening visit.
On average, how many clinical trials do you have going at one time?
NHI generally has 10-15 active clinical trials, with about 5-20 participants per trial. We try to match the clinical trial to the patient's most pressing health needs.
What does it mean to be in a blinded and randomized clinical trial?
To collect non-biased scientific information, most trials are performed in a blinded fashion. This means that neither you nor the clinical trial staff will know if you are receiving the drug being studied or a placebo. Randomized means that your selection to receive either the study drug or placebo is randomly selected. Blinded and randomized studies are dependent on the specific trial design and study protocol and are not determined by NHI’s team. Blinded also means that research subjects in clinical trials should not seek out tests to determine if they are receiving the study drug or placebo. This is called unblinding and is a major protocol deviation and may preclude participation in clinical trials.
Why should I enroll in a trial when I may get a placebo?
Because whether you get the study drug or the placebo, we can compare the benefit of the study drug on top of your current standard of care mediation. In fact, the study team may make recommendations to your doctors or other healthcare professionals to be sure the standard of care medications you are receiving are optimized before you are enrolled in a trial. Having other expert professional eyes on your treatment is another benefit of clinical trial participation. Most of the time, the treatment being studied is only available in a clinical trial. That means if you do not want to participate in the trial, the chance of getting that treatment is 0% rather than 50-75% depending on the specific trial design.
What can I expect during an initial clinical trial visit?
The initial visit is called the screening visit. The study team will review specific health information to determine if you are a candidate for a specific trial. We will also obtain a comprehensive assessment of your medical history, including previous and current illnesses and surgical history.
Once a match is made, we will provide you with two forms to review:
- The informed consent form reviews the risks and benefits of participating in a trial. The California Clinical Trial Bill of Rights gives you the right to withdraw from a study at any time.
Then a physical exam and blood tests are performed. The results of the blood tests can take 10-14 days turn around. After that time, you'll find out if you are eligible for that trial. If you are not eligible, we can often find another trial you may be eligible for.
What should I bring to my first clinical trial/screening visit?
Please bring the most recent blood test results and a comprehensive and accurate list of all medication you are taking, the dose, and how many times a day you are taking it. It would also help you to bring your current medication bottles with you to this visit. It would also be helpful to have medical chart notes from your most recent visit with your primary care physician or cardiologist.
What else should I do to prepare for my first visit?
You will be asked to fast for 10 hours before your appointment. However, drinking plenty of water and taking your regular medications are okay to do during this 10-hour period before your visit.
What happens during a regular follow-up clinical trial visit?
You will be asked about changes in your health status and changes in medications from a previous visit, vital signs will be taken, a physical exam may be performed, blood drawn for analysis, and sometimes other study-specific tests. Some of the blood tests performed are not done routinely with your regular doctor visits and can provide important information regarding your health. This is another potential advantage of clinical trial participation. We will communicate with your primary care team about significant health issues we become aware of, regardless of whether they are related to the clinical trial. We will also ask you to bring in the containers of study drugs and any unused study drugs you have for each visit. We ask that you notify the research coordinator immediately if you are hospitalized for any reason.
What if I change my mind after I enroll or halfway through the trial?
First, we will try to understand the reason for your decision. We hope to enroll patients who are committed to the trial from beginning to end. Of course, we are aware of extenuating circumstances, and we try to work with patients to overcome those, as we do have some options. Withdrawing from a clinical trial can affect the trial results. If patients experience side effects, we try to manage them together. At the end of the day, you have the right to change your mind per the California Bill of Rights.
What is expected of me during a clinical trial?
We hope that you…
- are clear about the reason you are participating in a clinical trial.
- feel free to ask members of our study team about anything involving your trial.
- are compliant with taking study medications and study visits.
- notify the study team of any changes to your health status, including any recent hospitalizations.
- do not "break the blind" by having tests done to find out if you are on the study medication or placebo.