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A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy

About

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
12 Years
Maximum Age
17 Years

Inclusion Criteria:

  • Diagnosis of HCM
  • Presence of LVOT obstruction
  • Presence of symptoms

Exclusion Criteria:

  • Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction
  • Evidence of LVEF <50% in prior 6 months
  • Planned escalation in HCM therapy or upcoming intervention (eg, major cardiac surgery, HCM medication dose increase)

Other protocol-defined Inclusion/Exclusion criteria apply.

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Study Stats
Protocol No.
23-5208
Category
Heart/Cardiovascular Diseases
Pediatric and Prenatal Disorders
Contact
Meliyah Misciel Macaraig
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06253221
For detailed technical eligibility, visit ClinicalTrials.gov.