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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07716826

Acronym

IMPACT-CMH

Enrollment

150

Registered

2026-07-21

Start date

2026-09-01

Completion date

2026-12-01

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Keywords

Cardiomyopathy, Hypertrophic Obstructive, mavacamten, mitral valve, subvalvular structures

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
Change in NYHA functional class	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

Contacts

CONTACTDr Morgane HERRY, MD

impact@sfcardio.fr01 44 90 70 28

CONTACTPr Damien LOGEART, MD