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Study on the Safety of Starting Vericiguat at 5 mg in Patients with Chronic Heart Failure with Reduced Ejection Fraction

Verified siteInvestigationalNo 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 chronic heart failure with reduced ejection fraction, a condition where the heart is unable to pump blood effectively, leading to symptoms like fatigue and shortness of breath. The study will use a medication called vericiguat, also known by its code name BAY 1021189. Vericiguat is taken as a film-coated tablet and is being tested to see how well patients tolerate a starting dose of 5 milligrams.

The purpose of the study is to evaluate the tolerability of this starting dose in participants with chronic heart failure. Participants will begin with a 5 mg dose of vericiguat and continue for a period of two weeks. During this time, researchers will monitor the participants to ensure they can complete the two-week course without stopping the medication due to side effects or experiencing moderate to severe low blood pressure, known as hypotension.

The study will also observe any adverse effects, which are unwanted symptoms or reactions, that may occur between the start and end of the two-week period. The goal is to ensure that participants can continuously take the medication or resume it if there is any temporary interruption. This trial aims to provide valuable information on the safety and tolerability of vericiguat for individuals with chronic heart failure with reduced ejection fraction.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is confirmed to have chronic heart failure with reduced ejection fraction. This condition means the heart is not pumping blood as well as it should.

    Eligibility is determined by specific criteria, including a left ventricular ejection fraction (LVEF) of less than 45% and stable blood pressure readings.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure no recent changes in heart failure medication dosages and no planned medical procedures that could interfere with the study.

  3. Step 3

    Medication administration

    The participant begins taking the study medication, vericiguat, which is provided as a film-coated tablet known as BAY 1021189.

    The starting dose is 5 mg, taken orally once daily for a duration of two weeks.

  4. Step 4

    Monitoring period

    During the two-week period, the participant's ability to tolerate the medication is closely monitored.

    The primary goal is to complete the two-week course without stopping the medication or experiencing significant drops in blood pressure.

  5. Step 5

    Evaluation of side effects

    Any side effects or adverse events (AE) are recorded between the first and second visits.

    The absence of side effects related to the medication is a key focus during this period.

  6. Step 6

    Completion of initial phase

    The initial phase concludes with an evaluation of the participant's experience with the medication.

    Successful completion is defined by the continuous intake of the medication without significant issues.

Who can join the trial?

7 criteria

  • Have a history of chronic heart failure with a reduced ejection fraction (less than 45%). This means the heart is not pumping as well as it should.
  • Have a systolic blood pressure (the top number in a blood pressure reading) of at least 100 mmHg at the start of the study.
  • No changes in the doses of heart failure medications for a certain period before the study. This includes medications like beta blockers, ACE inhibitors, and others.
  • No planned medical procedures two weeks before or during the study.
  • Participants can be with or without a recent worsening heart failure event. This means they may have had a recent heart failure episode or not.
  • Participants must be adults, as the study includes age groups 3 and 4, which typically refer to adults.
  • Both male and female participants are eligible.

Who cannot join the trial?

3 criteria

  • Patients who do not have chronic heart failure with reduced ejection fraction. This means the heart is not pumping 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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Investigated drugs

Vericiguat is a medication being studied for its safety and how well it is tolerated in people with chronic heart failure with reduced ejection fraction. This medication is being tested to see if starting treatment with it is safe and manageable 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, specifically in a Phase 2b open-label study, to assess its safety and tolerability in patients with chronic heart failure with reduced ejection fraction. The main therapeutic indication for Vericiguat is to improve heart function in individuals with this type of heart failure. At the molecular level, Vericiguat works by stimulating an enzyme called soluble guanylate cyclase, which helps relax blood vessels and improve blood flow. It is classified pharmacologically as a soluble guanylate cyclase stimulator.

Investigated diseases

Chronic Heart Failure with Reduced Ejection Fraction – 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 fatigue, shortness of breath, and fluid retention may develop. The progression of the disease can lead to worsening heart function and increased difficulty in performing daily activities. As the heart struggles to meet the body's demands, patients may experience episodes of worsening symptoms, known as exacerbations. These exacerbations can lead to hospitalizations and require careful management to stabilize the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507682-25-00Protocol code21683 "VELOCITY"Estimated enrolment138 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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