Vericiguat for children with heart failure due to left ventricular dysfunction
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)
This study tests if the medication vericiguat is safe and helpful for children with heart failure caused by problems with the left side of their heart.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 342 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 7 sites (Memphis, Tennessee and 6 other locations) |
| Trial ID | NCT06428383 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of vericiguat in pediatric participants suffering from heart failure caused by left ventricular systolic dysfunction. Participants who have previously received vericiguat or placebo will be monitored over a 52-week period to assess the drug's effects. The study aims to determine how well children can tolerate the medication and its potential benefits in managing their condition.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients with heart failure due to left ventricular systolic dysfunction who have completed a prior study and meet specific health criteria.
Not a fit: Patients who are hypotensive or have known allergies to vericiguat will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve heart function and quality of life for children with heart failure.
How similar studies have performed: Other studies have explored treatments for heart failure in children, but the specific use of vericiguat in this population is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Memphis, Tennessee and 6 other locations
- Le Bonheur Children's Hospital ( Site 0007) — Memphis, Tennessee, United States (Recruiting)
- Clinica Somer-Unidad de Investigacion y Docencia ( Site 0607) — Rionegro, Antioquia, Colombia (Recruiting)
- Fundacion Valle del Lili- CIC ( Site 0604) — Cali, Valle Del Cauca, Colombia (Recruiting)
- Gottsegen György Országos Kardiovaszkuláris Intézet-Gyermeksziv Kozpont ( Site 1300) — Budapest, Hungary (Recruiting)
- Children's Health Ireland (CHI) at Crumlin ( Site 1400) — Dublin, Ireland (Recruiting)
- Faculty of Medicine Siriraj Hospital ( Site 3200) — Thailand, Krung Thep Maha Nakhon, Thailand (Recruiting)
- Maharaj Nakorn Chiang Mai Hospital-Department of Pediatrics ( Site 3201) — Chiang Mai, Thailand (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.