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

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II/III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
29 Days
Maximum Age
17 Years

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

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Study Stats
Protocol No.
22-5105
Category
Heart/Cardiovascular Diseases
Pediatric and Prenatal Disorders
Contact
Meliyah Misciel Macaraig
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05714085
For detailed technical eligibility, visit ClinicalTrials.gov.