Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction

This large study, called a Phase 3 trial, is investigating a new medication called vericiguat for adults living with chronic heart failure that has reduced pumping ability. Researchers want to find out if vericiguat can help stop people from dying from heart problems or needing to go to hospital for their heart failure, compared to taking a dummy pill (placebo). They are also carefully checking for any side effects of the drug. Participants will either receive vericiguat at different doses or a placebo. The main focus is to see how long it takes before a patient either dies from heart issues or needs to be hospitalised for heart failure. This type of study helps doctors understand if new treatments are effective and safe for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

2,214

Start

26 Apr 2023

Chronic Heart Failure With Reduced Ejection Fraction

What is this study about?

This research is looking at a new medication called vericiguat. It's designed for adults who have a long-term condition called chronic heart failure, specifically when their heart isn't pumping blood as strongly as it should be. This is often called 'heart failure with reduced ejection fraction'.

The main aim of this study is to see if vericiguat can help improve the health of people with this type of heart failure. Researchers want to find out if taking vericiguat can reduce the chances of serious events, such as dying due to heart problems or needing to go into hospital because of heart failure. They will be comparing the effects of vericiguat with a 'placebo', which is a dummy pill that looks like the real drug but contains no active medicine. This helps them understand if any changes are truly due to the new drug.

Alongside checking if the drug works, a very important part of the study is to make sure it's safe. The researchers will be closely monitoring all participants for any side effects, both mild and serious. The study will also track other important health outcomes, like how often people need to be hospitalised for heart failure and how the drug affects overall survival. This detailed approach helps doctors decide if vericiguat could be a useful new treatment option in the future.

Key takeaways

It's a large study testing a new drug, vericiguat, for a type of chronic heart failure.
It aims to see if vericiguat can prevent heart-related deaths and hospital stays.
Participants will receive either vericiguat or a dummy pill (placebo).
Safety and side effects are carefully monitored throughout the study.
It's open to adults aged 18 and over, of all sexes, with specific heart failure.
Taking part means regular clinic visits and health checks.

Who may be eligible?

To join this study, participants generally need to be 18 years old or older. There is no upper age limit, meaning older adults may also be able to take part.

Both men and women can participate in this research, as the study is open to all sexes.

The most important requirement is that you must have chronic heart failure where your heart's ability to pump blood is reduced. The research team will do medical tests to confirm if you meet all the specific health criteria for the study.

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 18 years old or older?
Do you have chronic heart failure?
Has your doctor told you your heart's pumping ability is reduced (reduced ejection fraction)?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the study drug, vericiguat (at one of two different doses), or a placebo (a dummy pill with no active ingredient). You wouldn't get to choose which one you receive.

You would need to attend regular appointments at the study clinic. During these visits, doctors and nurses would perform various checks, including physical examinations, blood tests, and heart monitoring (like ECGs), to see how you are doing and track your health. You would take the study medication regularly as instructed.

Throughout the study, the research team would closely monitor your health and any changes, including any side effects you might experience. The total duration of your participation would depend on the study design, but generally, these types of pivotal trials can last for several years, with regular follow-up to check on your long-term health and the effects of the treatment.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could potentially help your heart condition, and you'll receive careful medical monitoring. However, there's no guarantee the new drug will work for you, and it might have side effects that aren't yet fully known. There's also a chance you could receive the placebo, meaning you wouldn't get the active study drug. You would always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

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

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Unverified
Sweden
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Unverified
Spain
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Unverified
Hungary
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Unverified
Italy
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Unverified
Denmark
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Unverified
France
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Unverified
Ireland
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Unverified
Austria
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Unverified
Germany
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Unverified
Czechia
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Unverified
Poland
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Unverified
Greece

Common questions

What is chronic heart failure with reduced ejection fraction?

This is a long-term heart condition where your heart muscle struggles to pump enough blood around your body because it's not squeezing as strongly as it should.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers fairly compare the new drug's effects.

Why is this a 'Phase 3' study?

Phase 3 means this is a large, advanced stage of research designed to confirm if a drug is effective and safe in a bigger group of people, before it's considered for wider use.

Will I know if I'm getting the drug or the placebo?

During the study, neither you nor your doctor will typically know whether you are receiving the active drug or the placebo. This helps prevent bias in the results.

What are the main things the study wants to find out?

The study's main goal is to see if the new drug can reduce the chances of dying from heart problems or needing to be hospitalised for heart failure, and to check its safety.