RecruitingPHASE3INTERVENTIONAL

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction

This important study is testing a new drug called omecamtiv mecarbil for people living with a serious type of heart failure where the heart struggles to pump blood effectively. Doctors want to find out if this drug can help prevent serious problems linked to heart failure, such as needing to go to the hospital, having a heart transplant, or even reducing the risk of death. Participants will either receive the new drug or a placebo (a dummy pill) to fairly compare its effects. The study aims to gather enough information over approximately three years to understand if omecamtiv mecarbil is a safe and effective treatment to improve the lives of individuals with severe heart failure.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Cytokinetics

Enrolment target

1,800

Start

19 Dec 2024

Estimated completion

01 Dec 2027

Heart Failure Heart Failure With Reduced Ejection Fraction

What is this study about?

Heart failure is a condition where your heart can't pump enough blood around your body as well as it should. This study is focusing on a specific type called 'heart failure with reduced ejection fraction,' which means the main pumping chamber of your heart isn't squeezing strongly enough. When this happens, symptoms like breathlessness and tiredness can get worse, and people might need to go to hospital more often.

Researchers are investigating a new medication called omecamtiv mecarbil. They want to see if this drug can make a real difference in the lives of people with this severe form of heart failure. The main goal is to find out if taking omecamtiv mecarbil can lower the chance of serious health events, such as needing to be admitted to hospital for heart failure, requiring a heart transplant, or even reducing the risk of death related to heart problems.

To ensure a fair comparison, half of the participants will receive the active drug, and the other half will receive a 'placebo,' which looks exactly like the drug but contains no medicine. This helps doctors know if any improvements are genuinely due to the new drug or other factors. The study will continue until enough information has been collected from participants experiencing certain heart-related events, which could take up to three years.

Key takeaways

Tests a new drug (omecamtiv mecarbil) for severe heart failure.
Aims to reduce hospital stays, transplants, or death related to heart problems.
Compares the new drug to a dummy pill (placebo).
Participation could last up to three years.
Open to adults aged 18-85 with a specific type of chronic heart failure.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged between 18 and 85 years old who have been diagnosed with chronic heart failure for at least three months. You must be regularly taking a type of water tablet called a loop diuretic.

Crucially, your heart's main pumping chamber must be quite weak. Doctors will check this with a test called an ejection fraction. Depending on whether you have an irregular heartbeat (AFib), the required weak heart pump measurement will be slightly different. You also need to have recent evidence of your heart failure getting worse, such as a recent hospital stay, a heart event in the last year, or your doctors needing to increase your water tablet dose.

There are also some reasons why you might not be able to join. For example, if you have an irregular heartbeat (AFib) and are taking a specific medication called digoxin, or if you've recently had a heart attack, heart surgery, or other procedures that might have changed your heart's pumping ability.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Do you have chronic heart failure and receive treatment for it?
Are you regularly taking 'water tablets' (oral loop diuretics)?
Has your heart failure recently worsened (e.g., hospital stay, increased medication)?
Has your doctor told you your heart's pumping action is significantly weak?
Do you have AFib and are not currently taking digoxin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in the study for up to three years. You’ll be randomly assigned to either receive the new study drug, omecamtiv mecarbil, or a placebo (a dummy pill). You won't know which one you're receiving, nor will your study doctors. You'll need to attend regular appointments for check-ups, blood tests, and heart scans to see how you're responding to the treatment.

The study will continue until enough participants have experienced certain heart-related events (like a hospitalisation for heart failure or a cardiovascular death). This helps the researchers understand the drug's effects across a large group of people.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if you receive the active drug and it helps improve your heart condition or reduces the chances of serious heart problems. However, there's also a chance you could receive the placebo and not benefit directly from the new drug. As with any medication, there could be potential side effects, and these will be carefully monitored throughout the study. You're free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (185)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Advanced Cardiovascular, LLC
Verified postcode
Alexander City, United States· Recruiting
University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
Pima Heart and Vascular Clinical Research
Verified postcode
Tucson, United States· Withdrawn
National Heart Institute
Verified postcode
Beverly Hills, United States· Recruiting
UC San Diego Health - Sulpizio Cardiovascular Center
Verified postcode
La Jolla, United States· Recruiting
Nutrition Research Center (SPH)
Verified postcode
Loma Linda, United States· Recruiting
Keck Medical Center of USC (outpatient clinic)
Verified postcode
Los Angeles, United States· Recruiting
UCLA Medical Center Cardiovascular Clinic
Verified postcode
Los Angeles, United States· Recruiting
University of California, Irvine Medical Center
Verified postcode
Orange, United States· Recruiting
Sutter Institute for Medical Research (SIMR)
Verified postcode
Sacramento, United States· Recruiting
UC Davis Health
Verified postcode
Sacramento, United States· Recruiting
San Diego Cardiac Center
Verified postcode
San Diego, United States· Recruiting

Common questions

What is 'ejection fraction'?

Ejection fraction is a measurement of how well your heart's main pumping chamber squeezes out blood with each beat. A lower number means your heart isn't pumping as strongly as it should.

What does 'placebo' mean?

A placebo is a 'dummy' pill that looks just like the study drug but doesn't contain any active medicine. It's used to compare the real drug's effects fairly.

Can I continue my other heart failure medicines?

Yes, you are expected to be on your usual heart failure medications, which are considered the standard care in your region, for at least 30 days before joining the study.

How long will the study last for me?

Your participation in the study could last for up to three years, including regular check-ups and follow-up appointments.

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason, without it affecting your future medical care.

How to find out more

Cytokinetics MD

medicalaffairs@cytokinetics.com (650) 624-2929 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.