Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Sponsor
Shanghai Chest Hospital
Study ID
NCT06856265
Status
Not Yet Recruiting

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Conditions

  • Mavacamten
  • Obstructive Hypertrophic Cardiomyopathy
  • Radiofrequency Ablation

Eligibility Criteria

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

Interventions

  • radiofrequency ablation — PROCEDURE
    Radiofrequency Ablation is a minimally invasive interventional technique performed via catheter guidance. It utilizes thermal energy (50-80°C) generated by high-frequency alternating current (typically 300-750 kHz) to induce coagulative necrosis or electrophysiological isolation in targeted tissues, thereby eliminating abnormal electrical activity or mechanical obstruction. In the treatment of cardiomyopathy, RFA is applied to ablate hypertrophied myocardial tissue (e.g., the ventricular septum) to alleviate left ventricular outflow tract (LVOT) obstruction.
  • Mavacamten — DRUG
    Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations.

Study Details

This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM). Participants were randomized into two groups:

Key Dates

Start date
Feb 26, 2025
Status verified
Feb 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Mavacamten monotherapy
    Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations. Permitted Doses: Individualized doses included 1 mg, 2.5 mg, 5 mg, 10 mg, or 15 mg.
  • Experimental: Mavacamten combined with radiofrequency ablation
    Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations. Permitted Doses: Individualized doses included 1 mg, 2.5 mg, 5 mg, 10 mg, or 15 mg. Post-procedure Initiation: In the combination therapy group, Mavacamten was initiated within 24 hours after radiofrequency ablation.

Primary Outcome Measure

Change in Valsalva LVOT peak gradient from baseline to week 30, as determined by Doppler echocardiography. [ Time Frame: from baseline to week 30 ]

Central Contacts

  • Mu

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