Efficacy and Safety of an LVEF-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Sponsor
Second Affiliated Hospital of Nanchang University
Study ID
NCT07807384
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Obstructive Hypertrophic Cardiomyopathy (oHCM)

Eligibility Criteria

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

Interventions

  • Mavacamten — DRUG
    Eligible participants will undergo dose escalation at baseline from their current dose to the next higher level (once daily: 2.5 mg → 5 mg, 5 mg → 10 mg, or 10 mg → 15 mg). At Week 4, clinical status and echocardiography will be re-evaluated, and the same dose will be maintained for the subsequent 8 weeks, unless LVEF is \< 50%. After 12 weeks of treatment at the same dose level: If LVEF remains ≥ 55%, further dose escalation is permitted. If LVEF is between 50% and 55%, the current dose will be maintained. If LVEF is \< 50%, treatment will be interrupted/discontinued.

Study Details

This study aims to evaluate whether, under a treatment strategy primarily guided by left ventricular ejection fraction (LVEF), dose up-titration in adult patients with symptomatic obstructive hypertrophic cardiomyopathy who have received Mavacamten treatment for at least 12 weeks with a stable maintenance dose (as baseline) and with LVEF ≥55% can further reduce left ventricular outflow tract (LVOT) gradient after 24 weeks of treatment. It will also assess changes in hemodynamics, clinical symptoms, cardiac structure, and function. Furthermore, the study will conduct stratified analyses based on patients' baseline resting or Valsalva-provoked LVOT gradient levels at enrollment \[\<30 mmHg vs. ≥30 mmHg\] to explore differences in the aforementioned outcome measures among patients with different gradient levels, with the goal of providing evidence for individualized clinical dose adjustment.

Key Dates

First listed
Sep 8, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
115 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mavacamten

Primary Outcome Measure

Change From Baseline in Valsalva Peak Left Ventricular Outflow Tract (LVOT) Pressure Gradient Assessed by Echocardiography at Week 24 [ Time Frame: Baseline, Week 4, Week 8, Week 12, and Week 24 ]

Central Contacts