Last updated 19 days ago

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

342 patients around the world

Available in Spain, Colombia, United States

As of Protocol Amendment 2, the separate open-label extension arm of study MK-1242-043 (NCT06428383) will be incorporated into the present MK-1242-036 study as an extension period. Participants from the Base Period will be provided the opportunity to participate in the optional open-label Extension Period if eligible. After all ongoing participants are transferred into the extension period of MK-1242-036, MK-1242-043 (NCT06428383) will be formally closed.

Merck Sharp & Dohme LLC

342Patients around the world

This study is for people with

Heart failure

Systolic heart failure

Requirements for the patient

To 17 Years

All Gender

Medical requirements

: 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

: 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

SponsorMerck Sharp & Dohme LLC

Study typeInterventional

Conditions

Systolic heart failure

Requirements

To 17 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05714085