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Clinical Trials in China / NCT07103655
Enrolling by invitation Phase 4

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

NCT07103655 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 4
Started
2026-03-01
Last updated
2026-09-15

Condition(s) studied

Hypertrophic Cardiomyopathy (HCM)

Investigational drug(s) / intervention(s)

mavacamtenBeta Blocker (BB) - metoprolol, bisoprolol, carvediloldiltiazem

mavacamten: 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: Administer an appropriate dose of beta-blockers according to the patient's tolerance.

diltiazem: Administer an appropriate dose of diltiazem according to the patient's tolerance.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Patients diagnosed with HCM according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Adult Hypertrophic Cardiomyopathy, meeting one of the following: 1. Left ventricular wall thickness ≥15 mm at end-diastole in any segment as assessed by echocardiography or cardiac magnetic resonance imaging (CMR); 2. Left ventricular wall thickness ≥13 mm in individuals with a confirmed pathogenic gene mutation or in genetically affected family members; 3. Exclusion of other cardiovascular, systemic, or metabolic disorders that may cause ventricular hypertrophy. * Symptomatic non-outflow tract obstructive HCM patients (meeting criterion a and at least one of b or c): <!-- --> 1. Presence of clinical symptoms such as dyspnea, chest pain, dizziness, palpitations, or syncope, with New York Heart Association (NYHA) functional class II-III; 2. Maximal pressure gradient (PGmax) \>30 mmHg in the mid-ventricle under resting or Valsalva maneuver as assessed by echocardiography; 3. PGmax \>30 mmHg in the apical region under resting or Valsalva maneuver on echocardiography. ③Ability to provide written informed consent (ICF) and any required privacy authorization prior to study enrollment. Exclusion Criteria: \- * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07103655 on ClinicalTrials.gov ↗ ← All trials in China