Clinical Trials for Heart Failure

Heart failure, or congestive heart failure (CHF), is a disease that occurs when your heart can no longer pump blood properly. It can lead to fatigue, shortness of breath, and the buildup of fluid in your body.1 Over the years, the U.S. Food and Drug Administration (FDA) has approved several medications to treat congestive heart failure — many of them help lower blood pressure and clear extra fluid out of your body to take the stress off your heart.2

Congestive heart failure can be well-managed with currently available medications, so doctors and researchers are now looking for new ways to monitor patients and prevent hospitalization. They’re also finding new ways to treat congestive heart failure using medications previously approved for other diseases.

Before treatments can be given to the general public, they must first go through clinical trials to prove they’re safe and effective. Investigators recruit volunteers with CHF to determine whether new monitoring methods, treatments, or diets may help reduce complications and limit the need for hospital stays. The clinical trials discussed below are just a fraction of current studies.

New Ways to Monitor Heart Failure

Clinical trials are not only for new drugs — they’re also required for new treatment strategies and medical devices used to monitor diseases. Congestive heart failure is a complex disease that needs to be treated properly for you to stay healthy. If it’s not well-managed, you may need more intensive treatment in the hospital. In fact, over 1 million people are hospitalized for congestive heart failure every year, costing billions of dollars.3

Doctors and researchers are now using more personalized approaches to treating diseases, especially congestive heart failure. Clinical trials are studying new ways to monitor patients so doctors can make treatment recommendations and prevent complications and hospitalization.

For example, different studies are using monitoring devices to track heart rate, blood pressure, and activity levels to track how well treatments are working. The investigators also perform tests to identify which patients are at risk of congestive heart failure complications. By using wearable devices, investigators can track participants’ recovery and watch for any signs of complications that may result in hospitalization.4,5

Previously Approved Therapies Applied to CHF

Previously approved treatments offer doctors and researchers new ways to treat other diseases. Since these therapies have already been shown to be safe in humans, they can be easily studied in other settings. Doctors and researchers have started investigating different diabetes medications for treating congestive heart failure. Type 2 diabetes occurs when your cells no longer use insulin properly to let sugar (glucose) in for energy. Some medications help your body make more insulin to help your cells, while others help them become more sensitive to insulin. Examples of FDA-approved treatments for type 2 diabetes include metformin, GLP-1 agonists such as semaglutide, and SGLT2 inhibitors such as ertugliflozin.6

Clinical trials studying these medications are recruiting participants without diabetes to determine their effects on congestive heart failure alone. Investigators are hoping these treatments may improve congestive heart failure symptoms — such as shortness of breath and reduced exercise capacity — while reducing the risk of hospitalization.

For example, semaglutide is currently being studied to help people with heart failure with preserved ejection fraction (HFpEF) lose weight and iprove their symptoms.7 Other studies are combining diabetes medications with diuretics, or “water pills,” to help get rid of excess fluid that may lead to swelling and shortness of breath.8-10

Joining a Heart Failure Clinical Trial

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If you or a loved one are living with congestive heart failure, you may want to learn more about clinical trials. Investigators list their studies with inclusion and exclusion criteria or a list of requirements you need to meet to participate. They’re set before a study begins to ensure the data are accurate and participants are safe. To join a congestive heart failure clinical trial, you may have to, for example:

  • Meet certain age and health requirements
  • Have a certain type or class of heart failure
  • Have been recently hospitalized

People have different reasons for joining a clinical trial — some people hope to benefit from experimental therapies, while others want to contribute to the advancement of medicine and science. Choosing to take part in a clinical trial is a major decision. Whatever your choice is, it should be what’s best for you.