The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07103655
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Hypertrophic Cardiomyopathy (HCM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • mavacamten — DRUG
    Add Mavacamten to guideline-directed standard medical therapy for patients with hypertrophic cardiomyopathy (HCM) and mid-to-apical left ventricular obstruction.
  • Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol — DRUG
    Administer an appropriate dose of beta-blockers according to the patient's tolerance.
  • diltiazem — DRUG
    Administer an appropriate dose of diltiazem according to the patient's tolerance.

Study Details

This study is a prospective interventional cohort study aimed at evaluating the therapeutic efficacy and clinical utility of Mavacamten-a targeted myosin inhibitor specifically developed for obstructive hypertrophic cardiomyopathy (HCM)-in patients with HCM characterized by mid-to-apical left ventricular obstruction.

Key Dates

Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Jul 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mavacamten
    Add-on use of mavacamten on top of guideline-directed standard medical therapy
  • Active Comparator: No mavacamten
    Guideline-directed standard medical therapy group

Primary Outcome Measure

Percentage change in pressure gradient during the Valsalva maneuver [ Time Frame: Week 36 ]

Central Contacts

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