COMET-HF

A Clinical Trial to Evaluate an Investigational Drug for Heart Failure with Severely Reduced Ejection Fraction

What is heart failure?

Heart failure (HF) affects more than 64 million people worldwide. It is a chronic (ongoing) condition in which the heart struggles to pump enough oxygen-rich blood to the rest of the body. Put simply, the heart cannot keep up with the body’s needs. Some people have heart failure with reduced ejection fraction (HFrEF), which means their heart isn’t pumping out as much blood as it should with each heartbeat.

People with HFrEF are at risk for other serious medical problems that could require hospitalization or even lead to death. Symptoms of heart failure include, but are not limited to:

  • tiredness
  • shortness of breath during daily activities
  • swelling in the feet, ankles, or stomach
  • fluid in the lungs
  • weight gain
  • chest pain

About COMET-HF

Clinical trial participation period: Now and ongoing

A clinical research trial

COMET-HF is a phase 3 clinical trial of a study medicine called omecamtiv mecarbil. The goal of COMET-HF is to learn if the study medicine is effective at lowering the risk for heart failure-related events and deaths, heart transplants, and strokes for people  who have HFrEF. The safety and tolerability of omecamtiv mecarbil will also be evaluated.

Omecamtiv mecarbil is an investigational drug that may help the heart pump better. Omecamtiv mecarbil is an investigational drug and is not currently approved for use by regulatory agencies like the FDA. Its safety and efficacy have not been established.

 

Participants with HFrEF and severely reduced ejection fraction less than 30% will be enrolled in COMET-HF at study sites. It is important for people from many different backgrounds to take part in this study so we can make sure the results apply to all people living with heart failure.

Participants will be randomly assigned to receive either omecamtiv mecarbil (the investigational medicine) or placebo (a substance that does not have any medicine in it). Participants, their study doctors, and the study teams will not know which group participants are assigned to. This is to protect the study results from being influenced by anyone.

Each participant is an important part of COMET-HF. Study participants who give their time and information to research like this can help improve healthcare options for people with heart failure.

This study is expected to last approximately 3 years and include about 2,000 adults with HFrEF across multiple countries. The length of time participants will be in the study depends on how many heart failure-related events, strokes, or cardiovascular deaths have happened by the time they enroll. Because the study ends when a set number of events happen across all participants, the length of each participant’s time in the study will vary based on when they enter the study. The study doctors will explain the length of the study to participants during their first study visit.

 

Before enrolling in the study, each potential participant will talk with the study doctor about their current medications and health conditions.

If the study is a good fit for them and they choose to participate, the participant will:

  • Take 25 mg of omecamtiv mecarbil twice daily orally for 2 weeks.
  • Have their blood drawn so the study team can:
    • Measure the amount of study medicine in the participant’s blood.
    • Personalize dosing of the study drug for each individual based on these levels.
    • Participants may receive 25 mg, 37.5 mg, or 50 mg doses based on blood levels.
  • Take the placebo twice daily for 2 weeks to make sure the study medicine is out of their system before the treatment period begins. The placebo looks like the study medicine, but does not have any active ingredient.

If a participant does well on the study medicine, they will be assigned to either the active study medicine group or to the placebo group. This assignment will be random, like flipping a coin.

  • Each participant will have an equal chance of receiving either the active study medicine, omecamtiv mecarbil, or the placebo.
  • Participants will receive their supply of active study medicine or placebo at in-person visits.

In the treatment period:

  • Participants assigned to the active study medicine group will take the assigned dose of omecamtiv mecarbil twice daily orally.
  • Participants assigned to the placebo group will take the placebo twice daily orally. Participants in the placebo group are very important to the study. They help the study team learn if taking the study medicine works better or is safer than not taking anything at all.
  • Participants, their study doctors, and the study teams will not know which group participants are assigned to. This is to protect the study results from being influenced by anyone. If a participant has a health emergency, their doctors will be able to find out if they are taking the active study medicine or the placebo.
  • Participants will continue taking all other medications in addition to the study medicine.

To learn if the study medicine is safe and works well for people with heart failure with severely reduced ejection fraction, this study will look at the time it takes for participants to have specific heart failure-related events.

The COMET-HF study teams will check participants’ overall health throughout the study.

Omecamtiv mecarbil is an investigational drug, which means it has not been approved by any regulatory agency. Its safety and effectiveness have not
been established.

Interested in participating in COMET-HF?

This study will enroll participants in the United States, Canada, and Europe.

Details about enrollment requirements and contact information for study sites are provided in the study record on ClinicalTrials.gov (NCT06736574). Sites are added to the study record as they begin enrolling participants.

People who want to learn more about the COMET-HF study may email [email protected].

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