Cardiomyopathy, Hypertrophic ObstructiveIMPACT-CMHNCT07716826
IMPACT-CMH: Impact of Mitral Valve and Subvalvular Abnormalities in Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten
An observational study of Cardiomyopathy, Hypertrophic Obstructive, run by French Cardiology Society.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Hypertrophic Obstructive
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients who refuse to participate in this register
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Cardiomyopathy, Hypertrophic Obstructive
- Keywords
- Cardiomyopathy, Hypertrophic Obstructive, mavacamten, mitral valve, subvalvular structures
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 months after initiation of mavacamten
Secondary outcomes (1)
Change in NYHA functional class
The association between the type of baseline mitral valvular and/or subvalvular anatomical abnormalities and clinical response will be assessed
Measured: Baseline and 6 months after initiation of mavacamten
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, Hypertrophic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgane HERRY, Principal investigator, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716826
- Sponsor's protocol ID
- 2026-06-04
- Acronym
- IMPACT-CMH
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT-CMH: Impact of Mitral Valve and Subvalvular Abnormalities in Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten
- ClinicalTrials.gov ID
- NCT07716826
- Acronym / sponsor ID
- IMPACT-CMH / 2026-06-04
- Conditions
- Cardiomyopathy, Hypertrophic Obstructive
- Keywords
- Cardiomyopathy, Hypertrophic Obstructive, mavacamten, mitral valve, subvalvular structures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who refuse to participate in this register
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Change in NYHA functional class
Time frame: Baseline and 6 months after initiation of mavacamten
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Morgane HERRY principal investigator
Hopital Lariboisière
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, Hypertrophic Obstructive, run by French Cardiology Society.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Morgane HERRY, MD (01 44 90 70 28 ext. +33, impact@sfcardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.