Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Study ID
NCT07529938
Status
Completed

Conditions

  • Hypertrophic Cardiomyopathy (HCM)
  • Obstructive Hypertrophic Cardiomyopathy (oHCM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mavacamten — DRUG
    Mavacamten was administered as part of routine clinical care for patients with obstructive hypertrophic cardiomyopathy. This observational study did not assign interventions; instead, patients were categorized based on treatments received in real-world clinical practice. The initial dose was 2.5 mg once daily, with dose adjustments based on left ventricular ejection fraction and LVOT gradient as clinically indicated.

Study Details

This retrospective cohort study aims to evaluate the clinical efficacy and safety of mavacamten in adult patients with obstructive hypertrophic cardiomyopathy (oHCM). A total of 222 patients were included and categorized based on treatments received in routine clinical practice into a mavacamten group and a standard therapy group. The primary outcome is the change in resting left ventricular outflow tract (LVOT) gradient at Week 30. Secondary outcomes include changes in Valsalva LVOT gradient, New York Heart Association (NYHA) functional class, cardiac biomarkers, and echocardiographic parameters. Safety outcomes include adverse events and left ventricular systolic dysfunction. This study provides real-world evidence on the effectiveness and safety of mavacamten in Chinese patients with oHCM.

Key Dates

Start date
Jan 1, 2024
Status verified
Apr 2026
Primary completion
May 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
222 participants (actual)

Arms

  • Arm: Mavacamten Group
    Adult patients with obstructive hypertrophic cardiomyopathy (oHCM) who received mavacamten as part of routine clinical practice. Patients were not assigned to interventions but were categorized based on treatment received.
  • Arm: Standard Therapy Group
    Adult patients with obstructive hypertrophic cardiomyopathy (oHCM) who received standard pharmacological therapy, including beta-blockers or non-dihydropyridine calcium channel blockers, in routine clinical practice.

Primary Outcome Measure

Change in Resting Left Ventricular Outflow Tract (LVOT) Peak Gradient at Week 30 [ Time Frame: Baseline to Week 30 ]

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