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Soluble Guanylate Cyclase Stimulator

Vericiguat for Heart Failure

Phase 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a Left ventricle ejection fraction (LVEF) of <45% assessed within 12 months before Visit 1 by any local imaging method, with no subsequent LVEF measurement >45%. The most recent measurement must be used to determine eligibility.
No changes in guideline-directed medical therapy for heart failure (GDMT) dosing, including various medications, within specific timeframes as outlined.
Must not have
Hypertrophic cardiomyopathy
Amyloidosis or sarcoidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 up to day 18 (if +4 days time window is used)
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at a new way to treat chronic heart failure with reduced ejection fraction (HFrEF). The study is testing whether starting the medication vericiguat at a dose of

Who is the study for?
This trial is for adults with chronic heart failure who have a weak heart muscle (ejection fraction less than 45%). They should be stable on standard treatments, with or without a recent worsening of their condition. Blood pressure must be at least 100 mmHg. Those with planned medical procedures within two weeks before or during the study can't join.
What is being tested?
The safety of starting the approved heart failure drug Vericiguat at a higher initial dose of 5 mg is being tested. Participants will take this daily alongside their regular medications to see if it's tolerable and helps reach the target dose faster.
What are the potential side effects?
Possible side effects include low blood pressure, upset stomach, nausea, dizziness, and headache. These are monitored closely by researchers to manage any issues that arise during the four-week study period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is below 45%.
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My heart failure medication doses have been stable recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with thickened heart muscles.
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I have been diagnosed with amyloidosis or sarcoidosis.
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I have heart issues due to fast heart rate or uncontrolled irregular heartbeat.
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I am allergic to vericiguat or similar medications.
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I am taking or plan to take medication for erectile dysfunction.
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I have had a recent heart attack or heart surgery in the last 3 months.
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I have an active heart infection or a tight heart sac.
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I have a history of congenital heart disease, simple or complex.
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I have not had unstable blood pressure or fluid levels in the last 4 weeks.
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I am currently in the hospital.
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My liver is not working well.
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I need to use oxygen at home all the time for my severe lung condition.
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I have a lung condition that affects the tissue and space around the air sacs.
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I am currently taking medication that stimulates sGC, like riociguat or vericiguat.
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I have been diagnosed with acute myocarditis or Takotsubo cardiomyopathy.
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I am waiting for or have had a heart transplant.
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My kidney function is very low or I am on chronic dialysis.
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My life expectancy is less than 3 years due to my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 14 (up to day 18 if +4 days time window is used)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 14 (up to day 18 if +4 days time window is used) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the treatment tolerability defined as the number of participants completing the two-week 5 mg dose without discontinuation of study intervention
Evaluate the treatment tolerability defined as the number of participants completing the two-week 5 mg dose without moderate to severe hypotension between Visit 1 and Visit 2
Secondary study objectives
Any AE reported between Visit 1 and Visit 2.
Number of participants able to continuously take study intervention between Visit 1 and Visit 2 or to restart study intervention after any temporary interruption.
Number of participants without AEs related to the study intervention between Visit 1 and Visit 2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Overall studyExperimental Treatment1 Intervention
At Visit 1 participants will receive 1x 5 mg Vericiguat (BAY1021189) tablet daily (on top of standard of care) for at least 14 days to max 18 days (+4 days time window allowed)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vericiguat (BAY1021189) 5 mg
2024
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,985 Previous Clinical Trials
5,178,595 Total Patients Enrolled
25 Trials studying Heart Failure
20,513 Patients Enrolled for Heart Failure
BayerLead Sponsor
2,270 Previous Clinical Trials
25,508,626 Total Patients Enrolled
50 Trials studying Heart Failure
63,466 Patients Enrolled for Heart Failure
~71 spots leftby Oct 2025
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