Clinical trials for Heart Health conditions now enrolling

A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational medicine or treatment. Clinical trials are conducted by doctors and researchers. Clinical research helps doctors and scientists determine if an investigational medicine or therapies are safe and/or effective for use in humans to potentially treat a condition, disease, or disorder.

Before regulatory authorities that are responsible for approving medicines for use in each country can consider an investigational medicine, device, or procedure for approval, it must be shown to be both safe and work well, or the overall benefits outweigh the risks. Typically, this is accomplished through clinical trials.

Clinical trials must be reviewed by an Institutional Review Board (IRB) or Ethics Committee (EC). An IRB or EC is a group that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with medical tests and study-related exams before, during, and sometimes even after the trial.

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 in other diseases or conditions. An investigational medication or vaccine 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.

There are always risks and benefits of participating in a clinical research study. There is always a chance that the potential new medication could cause side effects or will not work. However, you should know that there are strict rules in place to monitor the safety of people taking part in a study. Before joining any clinical research study, it is important to consider the risks and understand them. The study team will explain all the risks and benefits at the first study visit. Throughout the study, a team of doctors and nurses will monitor the health of the people taking part. They will be there to answer any questions you may have.

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 form. You will be told immediately if there is a match. If you or your loved one pre-qualify, we will connect you to a clinical research study center in your 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. 

All personal information will remain confidential, and data will only be collected and used as necessary to support an individual’s match to and participation in a study. Participants’ names will not be included in any data reported. For more information, including how and why we process personal data, please read our Privacy Policy.

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 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 condition in the future.

People taking part in the study will need to follow all the instructions from the study doctor and nurses.