Study

Overview

Official Title: A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants with Heart Failure due to Systemic Left Ventricular Systolic Dysfunction (VALOR)

This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16. The primary hypothesis is Vericiguat is superior to placebo in reducing NT-proBNP at Week 16.

Study Type:

Interventional

Study Phase:

Phase 2/Phase 3

Estimated Enrollment:

342

Study Start Date:

May 2023

Estimated Study Completion Date:

April 2030

Estimated Primary Completion Date:

April 2030

Eligibility

Ages Eligible for Study:

29 days to 17 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

Inclusion Criteria:

Has a history of symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction
Has biventricular physiology with a morphologic systemic left ventricle
Is currently receiving stable medical therapy for HF
Has left ventricular ejection fraction (LVEF) <45% assessed within 3 months before randomization
Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed

Exclusion Criteria:

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 a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator
Has a history of single ventricle heart disease or has a morphologic systemic right ventricle
Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device
Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy
Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations
Has unoperated or residual hemodynamically significant congenital cardiac malformations
Has hypertrophic or restrictive cardiomyopathy
Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis
Has severe pulmonary hypertension
Requires continuous home oxygen for significant pulmonary disease and/or has known interstitial lung disease
Has severe chronic kidney disease
Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C
Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications
Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator

Locations

United States Toll Free Number 1-800-770-4674

Loma Linda, California, 92354
Los Angeles, California, 90095
Aurora, Colorado, 80045
Washington, District of Columbia, 20010
Saint Petersburg, Florida, 33701
Atlanta, Georgia, 30322
St. Louis, Missouri, 63110
Bronx, New York, 10467
New York, New York, 10032
Cleveland, Ohio, 44195
Philadelphia, Pennsylvania, 19104
Pittsburgh, Pennsylvania, 15224
Memphis, Tennessee, 38103
Seattle, Washington, 98105

Canada Study Coordinator 819-346-1110 ext 70454

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-1242-036

Study Detail

Efficacy, safety, and pharmacokinetics of vericiguat in pediatric participants with heart failure due to left ventricular systolic dysfunction (MK-1242-036)