ClinicalTrials.gg
Enrolling by invitationNCT07103655BRAVE-HCMUpdated Sep 15, 2026

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

A Phase 4 interventional study of mavacamten and Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol in Hypertrophic Cardiomyopathy (HCM), sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
132
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic — 3 open to participants now, 7 under way, 1 of them phase 3. MYK-461 · Cardiomyopathy, Hypertrophic.

Planned enrollment
5th of 21
132 · median 75
Started
2026
with 2 others
Phase 4
4 of 21
2 open now
Registered
19th of 21
by date
Lead sponsor
1 of 21
Second Affiliated Hospital, Zhejiang University, School of Medicine

Among the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic, this one is the 5th largest by planned enrollment, is one of 3 that started in 2026, is one of 4 in phase 4, and was the 19th registered.

Cardiomyopathy, Hypertrophic

363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.

This study's planned enrollment of 132 is above the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Open to participants now

3 of the 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic are open now, in 2 countries. Each count lists the studies.

All 3 open studies →

About MYK-461

MYK-461: first FDA approval 2022 (CAMZYOS), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 81 Cardiomyopathy, Hypertrophic studies recruiting now, 55 (68%) set no upper age limit and 8 (10%) stop at 75 or younger; 21 take children under 18; 13 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies testing MYK-461 in Cardiomyopathy, Hypertrophic, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Hypertrophic Cardiomyopathy (HCM)
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with HCM according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Adult Hypertrophic Cardiomyopathy, meeting one of the following:

    1. Left ventricular wall thickness ≥15 mm at end-diastole in any segment as assessed by echocardiography or cardiac magnetic resonance imaging (CMR);
    2. Left ventricular wall thickness ≥13 mm in individuals with a confirmed pathogenic gene mutation or in genetically affected family members;
    3. 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):

    <!-- -->

    1. Presence of clinical symptoms such as dyspnea, chest pain, dizziness, palpitations, or syncope, with (NYHA) functional class II-III;
    2. Maximal pressure gradient (PGmax) >30 mmHg in the mid-ventricle under resting or Valsalva maneuver as assessed by echocardiography;
    3. PGmax >30 mmHg in the apical region under resting or Valsalva maneuver on echocardiography.

      ③Ability to provide written (ICF) and any required privacy authorization prior to study enrollment.

Exclusion criteria

Exclusion Criteria:

-

  • 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 (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 .
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    Mavacamten

    Add-on use of mavacamten on top of guideline-directed standard medical therapy

    Drug: mavacamten · Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol · Drug: diltiazem

  • Active comparator
    No mavacamten

    Guideline-directed standard medical therapy group

    Drug: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol · Drug: diltiazem

Interventions

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

    Also known as: beta receptor blockers

  • DrugBeta Blocker (BB) - metoprolol, bisoprolol, carvedilol

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

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: Week 36

Secondary outcomes

  1. Anterior papillary muscle to the interventricular septum distance

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Week 36

  7. BNP

    Number decrease in BNP levels from baseline to week 36.

    Time frame: Week 36

  8. Troponin T

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

    Time frame: Week 36

  9. New-onset atrial fibrillation

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

    Time frame: 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.

    Time frame: From baseline to week 36

  11. LVEF<40%

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

    Time frame: From baseline to week 36

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Nov 2026, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2025
First posted
Aug 5, 2025
StartActual
Mar 1, 2026
Primary completionEst.
Nov 1, 2026
CompletionEst.
Jan 1, 2027
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07103655
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Responsible party
xie xiaojie (MD, PhD, Second Affiliated Hospital, Zhejiang University, School of Medicine) — Principal investigator
First posted
Aug 5, 2025
Start date
Mar 1, 2026
Primary completion
Nov 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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