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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Left ventricular wall thickness ≥15 mm at end-diastole in any segment as assessed by echocardiography or cardiac magnetic resonance imaging (CMR);

Left ventricular wall thickness ≥13 mm in individuals with a confirmed pathogenic gene mutation or in genetically affected family members;

Exclusion of other cardiovascular, systemic, or metabolic disorders that may cause ventricular hypertrophy.

Presence of clinical symptoms such as dyspnea, chest pain, dizziness, palpitations, or syncope, with New York Heart Association (NYHA) functional class II-III;

Disqualifiers

Obstructive hypertrophic cardiomyopathy (HCM), defined as a maximal left ventricular outflow tract pressure gradient (LVOT-PGmax) ≥30 mmHg at rest and during the Valsalva maneuver on echocardiography;

Maximal right ventricular outflow tract pressure gradient (RVOT-PGmax) ≥16 mmHg at rest; ③ Left ventricular ejection fraction (LVEF) <50% on echocardiography;

Uncontrolled primary hypertension;

Moderate or severe aortic valve stenosis and/or primary mitral valve disease with severe mitral regurgitation; ⑥ Known infiltrative or storage disorders mimicking the HCM phenotype (e.g., Fabry disease, cardiac amyloidosis); ⑦ Presence of severe infections, hepatic dysfunction, renal impairment, or other serious conditions significantly affecting life expectancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: MavacamtenExperimental treatment 3 interventions
Group B: No mavacamtenActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percentage change in pressure gradient during the Valsalva maneuver

The percentage reduction in the pressure gradient at the site of left ventricular obstruction during the Valsalva maneuver at week 36, compared to baseline, as measured by echocardiography.

Time frame
Week 36

Secondary outcomes

1

Anterior papillary muscle to the interventricular septum distance

Percentage Increase in the distance from the anterior papillary muscle to the interventricular septum

Time frame
Week 36
2

Left atrial global longitudinal strain

Left Atrial Global Longitudinal Strain (LA GLS) is an echocardiographic parameter derived from speckle-tracking imaging that measures the longitudinal deformation of the left atrial myocardium throughout the cardiac cycle.

Time frame
Week 36
3

Left ventricular global longitudinal strain

Left Ventricular Global Longitudinal Strain (LVGLS) is a sensitive echocardiographic parameter derived from speckle-tracking imaging that quantifies the myocardial deformation in the longitudinal direction. It reflects the shortening of myocardial fibers along the long axis of the left ventricle during systole.

Time frame
Week 36
4

Percentage change in resting pressure gradient

The percentage reduction in the pressure gradient at the site of left ventricular obstruction at rest measured by echocardiography at week 36 compared to baseline.

Time frame
Week 36

Other outcomes

Sponsors and contacts

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