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Soluble Guanylate Cyclase Stimulator

Vericiguat for Heart Failure

Phase 2 & 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has biventricular physiology with a morphologic systemic left ventricle

Is currently receiving stable medical therapy for HF

Must not have

Is clinically unstable-with at least one of the following: hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic or oral diuretic dose increase

Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up includes data collected up to a maximum of approximately 8 years

Summary

This trial will compare Vericiguat to placebo to see if it reduces a heart-related protein, NTproBNP, in 16 weeks.

Who is the study for?

This trial is for pediatric patients with heart failure due to left ventricular systolic dysfunction who are on stable heart failure medication, have a systemic left ventricle, and an ejection fraction below 45%. Participants must not be pregnant or breastfeeding and use effective contraception if applicable. Exclusions include recent cardiovascular procedures, significant congenital cardiac malformations, severe pulmonary hypertension or kidney disease, liver disorders, clinical instability requiring intensive treatment, known allergies to vericiguat or similar drugs.

What is being tested?

The study tests the effectiveness of Vericiguat (in suspension/tablet form) compared to a placebo in reducing NT-proBNP levels at Week 16 in children with heart failure. The primary goal is to see if Vericiguat can better decrease these biomarker levels indicative of heart stress than a non-active placebo.

What are the potential side effects?

While specific side effects for pediatric use may not be fully established yet, potential side effects based on adult usage could include low blood pressure (hypotension), dizziness upon standing up (orthostatic hypotension), headache, nausea and fatigue. Allergic reactions are also possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart has two working chambers with the main pumping chamber being on the left.

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I am on a stable treatment plan for heart failure.

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I have a history of heart failure due to weak heart muscle pumping.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been unstable with low blood pressure or needed strong heart or blood pressure medications recently.

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I recently had heart surgery to fix a birth defect.

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I have a stomach or bile duct condition that affects how my body handles medicine.

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I need home oxygen for my lung condition or have interstitial lung disease.

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I have been diagnosed with or am currently experiencing myocarditis.

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I am allergic to vericiguat or similar medications.

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I have severe heart issues, possibly awaiting or have had a heart transplant, or I'm on continuous heart support.

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I have a heart rhythm problem that isn't controlled by medication or devices.

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I have severe high blood pressure in the lungs.

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I have a condition where my heart muscle is abnormally thick or stiff.

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I am taking or plan to take medication for erectile dysfunction or heart/lung conditions.

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I have severe chronic kidney disease.

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I have a severe liver condition.

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I have a serious heart defect that hasn't been fully corrected by surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ includes data collected up to a maximum of approximately 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~includes data collected up to a maximum of approximately 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and includes data collected up to a maximum of approximately 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)

Extension Period: Percentage of participants who discontinued study drug due to an AE

Extension Period: Percentage of participants with one or more adverse events (AEs)

Secondary study objectives

Base Period: Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat

Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP

Base Period: First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Extension Period: VericiguatExperimental Treatment2 Interventions

Participants in the Extension Period receive either 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form; following completion of the Base Period.

Group II: Base Period: VericiguatExperimental Treatment2 Interventions

Participants in the Base Period receive 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form for 52 weeks; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form for 52 weeks.

Group III: Base Period: PlaceboPlacebo Group2 Interventions

Participants in the Base Period receive placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks.

0 / 17Eligibility criteria met