Testing whether beta-blockers can be dropped once mavacamten steadies a thickened heart

NCT ID NCT07815301

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether adults with obstructive hypertrophic cardiomyopathy can safely taper off beta-blockers after their heart condition has stabilized on mavacamten. The trial enrolls 286 people aged 18 to 75 who have been on a stable dose of mavacamten and one beta-blocker. Half will gradually reduce their beta-blocker dose over about 12 weeks, while the other half stay on their usual dose. The main question is whether the tapering group keeps stable heart function and symptoms through 24 weeks without needing rescue treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sequential tapering and discontinuation of beta-blockers
What this could lead to
If successful, this could show that some people with obstructive hypertrophic cardiomyopathy can safely stop taking beta-blockers once mavacamten controls their condition, reducing pill burden and side effects.
What could go wrong
Tapering beta-blockers may cause heart function to worsen or symptoms to return, and the trial may show that stopping is not safe for everyone. Results may not apply to people on different doses or with other heart conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 286 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 to 75 years. 2. Diagnosis of obstructive hypertrophic cardiomyopathy (oHCM). 3. Receiving mavacamten for ≥12 weeks at screening, with the current maintenance dose stable for ≥8 weeks; after completion of the 4-week run-in period, the total duration of mavacamten treatment at randomization should generally be ≥16 weeks. 4. Receiving one and only one beta-blocker continuously for at least 4 weeks before randomization, with the beta-blocker type, dosing frequency, and daily dose remaining stable, and without concomitant use of a non-dihydropyridine calcium channel blocker. 5. The last qualified echocardiographic assessment before randomization shows a resting left ventricular outflow tract (LVOT) peak gradient \<30 mmHg and a Valsalva-provoked LVOT peak gradient \<50 mmHg. 6. Left ventricular ejection fraction (LVEF) ≥55% at randomization baseline. 7. Clinically stable and considered by the investigator to be suitable for sequential tapering and discontinuation of beta-blocker therapy. Exclusion Criteria: 1. Previous LVEF \<50% during mavacamten treatment, or previous interruption or discontinuation of mavacamten because of reduced left ventricular systolic function. 2. Heart failure decompensation requiring an emergency department visit, hospitalization, or intravenous treatment within 3 months before randomization; or, within 6 months before randomization, syncope not attributable to a clearly reversible cause, sustained ventricular tachycardia/ventricular fibrillation, or other clinically significant unstable arrhythmia. 3. Septal reduction therapy within 6 months before randomization, or anticipated need for surgical septal myectomy, alcohol septal ablation, or other septal reduction therapy during the 24-week study period. 4. A definite indication for beta-blocker therapy other than oHCM for which the investigator considers dose reduction or discontinuation unsafe. 5. An HCM phenocopy or another disease clearly responsible for left ventricular hypertrophy, including cardiac amyloidosis, Fabry disease, or other infiltrative, storage, or metabolic cardiomyopathies. 6. Moderate-to-severe valvular heart disease, fixed left ventricular outflow tract obstruction, or another structural heart disease that may substantially affect LVOT gradients or assessment of the primary outcome. 7. Severe renal impairment (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²), end-stage renal disease, or ongoing dialysis. 8. Severe hepatic impairment (Child-Pugh class C), decompensated liver disease, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal at screening, or other severe hepatic dysfunction considered by the investigator to potentially affect the safe use of mavacamten. 9. Active malignancy, ongoing systemic anticancer therapy that may substantially interfere with study assessments, or an anticipated life expectancy \<1 year because of a serious comorbid condition. 10. Pregnancy or breastfeeding, planned pregnancy during the study, or, for participants of childbearing potential, inability or unwillingness to use effective contraception. 11. A drug interaction that cannot be adequately modified or avoided and may substantially affect mavacamten exposure, or anticipated need for continued use of a protocol-prohibited medication during the study. 12. Other serious systemic disease, inability to complete the required follow-up or comply with the study protocol, or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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Contacts and locations

Locations

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 32500, China

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