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

NCT07716826 | Not Yet Recruiting

• 1 other identifier: 2026-06-04
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in the highest left ventricular outflow tract (LVOT) Doppler maximal gradient (rest or Valsalva) from baseline to 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

  Baseline and 6 months after initiation of mavacamten

Secondary Outcomes (1)

• Change in NYHA functional class

  Baseline and 6 months after initiation of mavacamten

Study Arms (1)

Patient with a diagnosis of HCM with significant obstruction

Patient with a diagnosis of HCM with significant obstruction (left intraventricular gradient at rest or during Valsalva maneuver ≥ 50 mmHg) and symptomatic (NYHA class 2 or 3) and started treatment with Mavacamten

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a diagnosis of HCM with significant obstruction (left intraventricular gradient at rest or during Valsalva maneuver ≥ 50 mmHg) and symptomatic (NYHA class 2 or 3) and started treatment with Mavacamten

You may qualify if:

• 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

You may not qualify if:

• Patients who refuse to participate in this register

Sponsors & Collaborators

• French Cardiology Society: lead

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Morgane HERRY

  Hopital Lariboisière

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Morgane HERRY, MD

CONTACT

01 44 90 70 28; impact@sfcardio.fr

Pr Damien LOGEART, MD

CONTACT

01 44 90 70 28; impact@sfcardio.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07