AzTrials
AzTrials

Hypertrophic Cardiomyopathy (HCM)Phase 4BRAVE-HCMNCT07103655

The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction

A Phase 4 study testing mavacamten, Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol and diltiazem in people with Hypertrophic Cardiomyopathy (HCM), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective interventional cohort study aimed at evaluating the therapeutic efficacy and clinical utility of Mavacamten-a targeted myosin inhibitor specifically developed for obstructive hypertrophic cardiomyopathy (HCM)-in patients with HCM characterized by mid-to-apical left ventricular obstruction. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertrophic Cardiomyopathy (HCM)
What is being tested?
mavacamten, Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol and diltiazem
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteChina
Study dates
1 Mar 2026to 1 Jan 2027
Phase
Phase 4
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with HCM according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Adult Hypertrophic Cardiomyopathy, meeting one of the following:
  • Left ventricular wall thickness ≥15 mm at end-diastole in any segment as assessed by echocardiography or cardiac magnetic resonance imaging (CMR);
  • Left ventricular wall thickness ≥13 mm in individuals with a confirmed pathogenic gene mutation or in genetically affected family members;
  • Exclusion of other cardiovascular, systemic, or metabolic disorders that may cause ventricular hypertrophy.
  • Symptomatic non-outflow tract obstructive HCM patients (meeting criterion a and at least one of b or c):
  • <!-- -->
Show all 10Show fewer
  • Presence of clinical symptoms such as dyspnea, chest pain, dizziness, palpitations, or syncope, with New York Heart Association (NYHA) functional class II-III;
  • Maximal pressure gradient (PGmax) >30 mmHg in the mid-ventricle under resting or Valsalva maneuver as assessed by echocardiography;
  • PGmax >30 mmHg in the apical region under resting or Valsalva maneuver on echocardiography.
  • ③Ability to provide written informed consent (ICF) and any required privacy authorization prior to study enrollment.

Who cannot join

  • -
  • Obstructive hypertrophic cardiomyopathy (HCM), defined as a maximal left ventricular outflow tract pressure gradient (LVOT-PGmax) ≥30 mmHg at rest and during the Valsalva maneuver on echocardiography;
  • Maximal right ventricular outflow tract pressure gradient (RVOT-PGmax) ≥16 mmHg at rest; ③ Left ventricular ejection fraction (LVEF) <50% on echocardiography;
  • Uncontrolled primary hypertension;
  • Moderate or severe aortic valve stenosis and/or primary mitral valve disease with severe mitral regurgitation; ⑥ Known infiltrative or storage disorders mimicking the HCM phenotype (e.g., Fabry disease, cardiac amyloidosis); ⑦ Presence of severe infections, hepatic dysfunction, renal impairment, or other serious conditions significantly affecting life expectancy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction: A Prospective, Interventional, Real-World Clinical Study.

This study is a prospective interventional cohort study aimed at evaluating the therapeutic efficacy and clinical utility of Mavacamten-a targeted myosin inhibitor specifically developed for obstructive hypertrophic cardiomyopathy (HCM)-in patients with HCM characterized by mid-to-apical left ventricular obstruction.

Being tested
mavacamten, Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol, diltiazem
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mavacamtenDrug

    Also called beta receptor blockers

    Add Mavacamten to guideline-directed standard medical therapy for patients with hypertrophic cardiomyopathy (HCM) and mid-to-apical left ventricular obstruction.

  • Beta Blocker (BB) - metoprolol, bisoprolol, carvedilolDrug

    Administer an appropriate dose of beta-blockers according to the patient's tolerance.

  • diltiazemDrug

    Administer an appropriate dose of diltiazem according to the patient's tolerance.

Study groups in NCT07103655
Study groupRoleWhat they receive
MavacamtenExperimentalAdd-on use of mavacamten on top of guideline-directed standard medical therapy
Receives: Drug: mavacamten; Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol; Drug: diltiazem
No mavacamtenActive comparatorGuideline-directed standard medical therapy group
Receives: Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol; Drug: diltiazem

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in pressure gradient during the Valsalva maneuver

    The percentage reduction in the pressure gradient at the site of left ventricular obstruction during the Valsalva maneuver at week 36, compared to baseline, as measured by echocardiography.

    Measured: Week 36

Secondary outcomes (11)

  1. Anterior papillary muscle to the interventricular septum distance

    Percentage Increase in the distance from the anterior papillary muscle to the interventricular septum

    Measured: Week 36

  2. Left atrial global longitudinal strain

    Left Atrial Global Longitudinal Strain (LA GLS) is an echocardiographic parameter derived from speckle-tracking imaging that measures the longitudinal deformation of the left atrial myocardium throughout the cardiac cycle.

    Measured: Week 36

  3. Left ventricular global longitudinal strain

    Left Ventricular Global Longitudinal Strain (LVGLS) is a sensitive echocardiographic parameter derived from speckle-tracking imaging that quantifies the myocardial deformation in the longitudinal direction. It reflects the shortening of myocardial fibers along the long axis of the left ventricle during systole.

    Measured: Week 36

  4. Percentage change in resting pressure gradient

    The percentage reduction in the pressure gradient at the site of left ventricular obstruction at rest measured by echocardiography at week 36 compared to baseline.

    Measured: Week 36

  5. Absolute change in pressure gradient during the Valsalva maneuver

    The absolute decrease in number of the pressure gradient at the site of left ventricular obstruction during the Valsalva maneuver measured by echocardiography at week 36 compared to baseline.

    Measured: Week 36

  6. The proportion of patients with a pressure gradient <30 mmHg during the Valsalva maneuver

    The proportion of patients with a pressure gradient <30 mmHg at the site of obstruction during the Valsalva maneuver at week 36.

    Measured: Week 36

  7. BNP

    Number decrease in BNP levels from baseline to week 36.

    Measured: Week 36

  8. Troponin T

    Number decrease in Troponin T levels from baseline to week 36.

    Measured: Week 36

  9. New-onset atrial fibrillation

    Rate of new-onset atrial fibrillation in each group during the study period

    Measured: From baseline to week 36

  10. LVEF<50%

    The proportion of patients in each group with LVEF <50% accompanied by signs and symptoms of heart failure worsening and/or an increase in BNP of ≥30% compared to the previous measurement during the study period.

    Measured: From baseline to week 36

  11. LVEF<40%

    Rate of LVEF <40% in each group during the study period.

    Measured: From baseline to week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start1 Mar 2026
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07103655
Sponsor's protocol ID
2025-1056
Acronym
BRAVE-HCM
Status last verified
Sep 2026
First submitted
29 Jul 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing mavacamten, Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol and diltiazem in people with Hypertrophic Cardiomyopathy (HCM), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

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 10 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in pressure gradient during the Valsalva maneuver (time frame: Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07103655.

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 15 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in