IMPACT-CMH: Impact of Mitral Valve and Subvalvular Abnormalities in Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiomyopathy, Hypertrophic Obstructive. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Change in NYHA functional class [Time frame: Baseline and 6 months after initiation of mavacamten]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07716826 · 2026-06-04