A clinical research study, also called a clinical trial or research study, is a carefully designed scientific evaluation of a potential new medication. Clinical research studies are conducted by doctors and researchers. A clinical research study helps to answer important questions about a potential new medication, such as:

• How safe is the potential new medication?

• Does it work?

A potential new (investigational) medication, also sometimes called an investigational drug or a study medication, has been tested in a laboratory. Based on those results, it has been approved by health regulatory authorities for testing in people. An investigational medication also may be a medication that is approved for the treatment of one disease or condition but is still under investigation for use in other diseases or conditions. An investigational medication can only be used in clinical research studies.

All potential new (investigational) medications must be tested in clinical research studies before they can be approved by authorities to be prescribed to patients. Without people taking part in these studies, we would have no new medications.

If you would like to know whether you or your loved one might be able to take part in the study, please fill out the questionnaire. You will be told immediately if there is a match. If you or your loved one pre-qualify, we will connect you/them to a clinical research study center in your/their area. We will also help schedule the first study appointment at the study center. Please note: During the screening process, the study doctor or study team will check additional criteria before someone can join the study.

The study-required potential new (investigational) medication or placebo will be provided at no cost. The person taking part in the study will also receive study-related care from a team of experienced doctors and nurses throughout the study at no cost.

Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.

Participating in a clinical research study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in the future. They must also understand the risks, such as unknown side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.

It is a personal decision to take part. Participation in a study is voluntary. Please also consider:

• If a decision is made to participate, you/the person taking part can withdraw at any time during the study.
• The study team will explain the possible benefits and risks of the study during the informed consent process.
• A person does not have to join any study if they don’t want to.
• A team of doctors and nurses will carefully monitor the health of people taking part during the study.
• The potential new (investigational) medication or placebo will be provided at no cost.
• Taking part in the study may help other people with heart disease in the future.