Clinical trial NCT06428383: Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-043)
Official title: A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Systolic Dysfunction
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 342
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to monitor the safety and tolerability of vericiguat.


Eligibility criteria: Inclusion Criteria:

* Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), and completed the Week 52 visit and safety follow-up period for the VALOR base study.
* A participant assigned female sex at birth is not pregnant or breastfeeding, and is not a participant/participants of childbearing potential (POCBP) or is a POCBP who Uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention., and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
* Is able to receive medication via the oral or gastric route .

Exclusion Criteria:

* Is hypotensive for age at Visit 1
* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC )stimulator.
* Has undergone heart transplantation or has an implanted ventricular assist device.
* Has severe chronic kidney disease
* Has hepatic disorder
* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study.
* Has concurrent or anticipated use of an sGC stimulator.
* Is both ≥18 years of age and vericiguat is commercially available to the participant

Primary outcomes:
measure: Participants with adverse events (AEs)
timeFrame: Up to approximately 8 years
measure: Participants who discontinued study drug due to an AE
timeFrame: Up to approximately 8 years
Secondary outcomes:
measure: Change from baseline in n-terminal pro-brain natriuretic peptide (NT-proBNP)
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital ( Site 0007)
state: Tennessee
city: Rionegro
country: Colombia
facility: Clinica Somer-Unidad de Investigacion y Docencia ( Site 0607)
state: Antioquia
city: Cali
country: Colombia
facility: Fundacion Valle del Lili- CIC ( Site 0604)
state: Valle Del Cauca
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300)
city: Dublin
country: Ireland
facility: Children's Health Ireland (CHI) at Crumlin ( Site 1400)
city: Thailand
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 3200)
state: Krung Thep Maha Nakhon
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Clinical Director
role: STUDY_DIRECTOR
References: