IMPACT-CMH: Impact of Mitral Valve and Subvalvular Abnormalities in Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten

The objective of this observational study is to evaluate the association between the presence of mitral valvular and/or subvalvular anatomical abnormalities prior to initiation of mavacamten and the hemodynamic response at 6 months in patients with obstructive HCM treated with mavacamten. The secondary objective is to determine the impact of different types of anatomical abnormalities of the mitral valve and subvalvular structures on the hemodynamic and clinical response to mavacamten.

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Key information

Conditions

Cardiomyopathy, Hypertrophic Obstructive Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

A retrospective observational cohort study that analyzes previously collected data and does not involve direct patient participation (methodology MR-004). The clinical and ultrasound parameters included in the protocol are obtained as part of patients' routine care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion Criteria :
Age ≥18 years
Patients who are informed and consent to participate
CMH with significant obstruction (left intraventricular gradient at rest or during Valsalva maneuver ≥ 50 mmHg) and symptomatic (NYHA class 2 or 3)
Patients who have started treatment with Mavacamten

Exclusion criteria

Patients who refuse to participate in this register

Treatment and study plan

Primary outcomes

Change in the highest left ventricular outflow tract (LVOT) Doppler maximal gradient (rest or Valsalva) from baseline to 6 months after initiation of mavacamten

Time frame: Baseline and 6 months after initiation of mavacamten

Comparison of the change in LVOT gradient according to the presence or absence of mitral valvular and/or subvalvular anatomical abnormalities at baseline

Secondary outcomes

Change in NYHA functional class

Time frame: Baseline and 6 months after initiation of mavacamten

The association between the type of baseline mitral valvular and/or subvalvular anatomical abnormalities and clinical response will be assessed

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Morgane HERRY, MD

CONTACT

[email protected]

01 44 90 70 28 ext. +33

Pr Damien LOGEART, MD

CONTACT

[email protected]

01 44 90 70 28 ext. +33

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: IMPACT-CMH

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 21, 2026
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed