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Study on the Effects of Vericiguat in Patients with Heart Failure with Reduced Ejection Fraction (HFrEF) Using the CardioMEMS HF System

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Vericiguat in patients with a condition known as heart failure with reduced ejection fraction (HFrEF). Heart failure is a condition where the heart is unable to pump blood effectively, and in this specific type, the heart's ability to pump blood is even more reduced. The study will involve the use of Vericiguat, which is taken as a film-coated tablet, and will also include a comparison with a placebo.

The purpose of the study is to investigate how Vericiguat affects patients with heart failure, particularly those who have a device called the CardioMEMS HF System implanted. This device helps monitor heart function. Participants in the study will receive either Vericiguat or a placebo, and the effects on their heart condition will be observed over a period of time. The study will look at how Vericiguat impacts certain heart-related measurements, such as the pressure in the pulmonary artery, which is a blood vessel that carries blood from the heart to the lungs.

Throughout the study, participants will take the medication orally, and the treatment period will vary depending on the dosage. The study aims to provide valuable information on the potential benefits of Vericiguat for people living with heart failure, helping to improve their quality of life and manage their condition more effectively.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, the initial visit involves a comprehensive health assessment. This includes reviewing medical history and confirming eligibility criteria, such as age and heart failure status.
The CardioMEMS system, a device used to monitor heart failure, must have been implanted at least two weeks prior to this visit.
Step 2
Randomization
Participants are randomly assigned to receive either vericiguat or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Treatment phase
The treatment phase involves taking the assigned medication orally. The medication options include Verquvo 2.5 mg, Verquvo 5 mg, or Verquvo 10 mg film-coated tablets, or a placebo.
The dosage may be adjusted based on the participant's response and tolerance. The frequency and duration of administration are determined by the study protocol.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor health status and treatment effects. These visits include assessments of heart function and measurement of diastolic pulmonary artery pressure (dPAP).
The study aims to evaluate the effect of vericiguat on dPAP and NT-proBNP levels, which are indicators of heart failure severity.
Step 5
End of study
The study is estimated to conclude by January 30, 2026. At the end of the study, a final evaluation is conducted to assess the overall impact of the treatment on heart failure symptoms and progression.

Who can join the trial?

8 criteria

Must be 18 years or older.
Must be able to provide informed consent, which means understanding the study and agreeing to participate.
Must have a CardioMEMS device implanted for medical reasons at least 2 weeks before the first visit. This is a small device that helps monitor heart conditions.
Must have a known condition called chronic heart failure with a left ventricular ejection fraction (LVEF) of less than 45%. This means the heart's left side is not pumping as well as it should, and this must be documented within the last 24 months using a heart imaging test.
Must have symptoms that fit into NYHA functional class II-IV. This is a way to describe how severe heart failure symptoms are, with class II being mild and class IV being severe.
Must be on the best possible and stable medical therapy for heart failure.
Must have a systolic blood pressure (SBP) of at least 100 mmHg. This is the top number in a blood pressure reading.
Must have a diastolic pulmonary artery pressure (dPAP) greater than 15 mmHg for more than 8 days in the last 14 days, as measured by the CardioMEMS system. This is a measure of pressure in the lungs' blood vessels.

Who cannot join the trial?

3 criteria

Patients who do not have heart failure with reduced ejection fraction (HFrEF). This is a condition where the heart does not pump blood as well as it should.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Verified sites

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Verified
Aarhus University Hospital
Aarhus, Denmark
Verified
Odense University Hospital
Odense, Denmark
Verified
Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

Vericiguat is a medication being studied for its effects on patients with heart failure with reduced ejection fraction (HFrEF). It is designed to help improve heart function and reduce the symptoms of heart failure. The trial aims to determine how well this medication works in managing heart failure symptoms and improving the quality of life for patients.

What is already known about the treatment

Vericiguat – Vericiguat is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating heart failure with reduced ejection fraction (HFrEF). The medication works by stimulating an enzyme called soluble guanylate cyclase, which helps to relax blood vessels and improve blood flow, thereby reducing the workload on the heart. Vericiguat is classified as a soluble guanylate cyclase stimulator and is being evaluated for its potential benefits in heart failure management.

Investigated diseases

Heart Failure with Reduced Ejection Fraction (HFrEF) – This condition occurs when the heart muscle is unable to pump blood effectively, leading to a reduced ejection fraction, which is a measure of how much blood the left ventricle pumps out with each contraction. Over time, the heart becomes weaker, and symptoms such as shortness of breath, fatigue, and fluid retention may develop. The progression of HFrEF can lead to worsening heart function and increased difficulty in performing daily activities. The heart's inability to pump efficiently can cause blood to back up in the lungs and other parts of the body, leading to congestion and swelling. As the condition advances, patients may experience more frequent hospitalizations and a decline in quality of life.