ClinicalTrials.gg
Not yet recruitingNCT07815301STEP-oHCMUpdated Sep 11, 2026

Gradual Tapering or Discontinuation of Beta-Blockers After Stabilization With Mavacamten Therapy

An interventional study of Beta-Blocker Sequential Tapering and Discontinuation and Beta-Blocker Baseline Stable-Dose Maintenance in Obstructive Hypertrophic Cardiomyopathy (oHCM), sponsored by First Affiliated Hospital of Wenzhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by First Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
286
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 71 studies in Cardiomyopathy, Hypertrophic with a site in China — 30 open to participants now, 43 under way, 2 of them phase 3. Cardiomyopathy, Hypertrophic · China.

Planned enrollment
7th of 39
286 · median 84
Started
2026
with 7 others
No phase
19 of 71
11 open now
Primary completion
2028-12
later than 39 of 42 live
Registered
70th of 71
by date

Among the 71 studies in Cardiomyopathy, Hypertrophic with a site in China, this one is the 7th largest by planned enrollment of the 39 interventional ones that give a count, is one of 8 that started in 2026, is one of 19 with no phase, reaches primary completion later than 39 of the 42 other live ones, and was the 70th registered.

Cardiomyopathy, Hypertrophic

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

Browse Cardiomyopathy, Hypertrophic studies →

Open to participants now

30 of the 71 studies in Cardiomyopathy, Hypertrophic with a site in China are open now. Recruiting first, the newest first:

25 more — sign in →

All 30 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

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.

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02

Study summary

This multicenter, randomized, open-label, parallel-group, non-inferiority trial will evaluate whether sequential tapering and discontinuation of beta-blockers is non-inferior to maintenance of the baseline stable beta-blocker dose in adult patients with obstructive hypertrophic cardiomyopathy (oHCM) who have achieved predefined clinical and hemodynamic stability during mavacamten treatment. Eligible participants will be randomly assigned in a 1:1 ratio to a sequential tapering and discontinuation group or a baseline stable-dose maintenance group. In the tapering group, the beta-blocker dose will be reduced stepwise approximately every 4 weeks, with complete discontinuation planned at Week 12 if predefined safety and stability criteria are met. Participants will be followed through Week 24. The primary objective is to compare the proportion of participants who maintain clinical and hemodynamic stability without protocol-defined treatment failure through Week 24. The feasibility and safety of complete beta-blocker discontinuation will also be evaluated.

Read the detailed description

Mavacamten can substantially reduce left ventricular outflow tract (LVOT) obstruction in patients with obstructive hypertrophic cardiomyopathy (oHCM). However, many patients continue to receive beta-blockers as background therapy after achieving clinical and hemodynamic stability, and prospective randomized evidence regarding whether beta-blockers can be safely tapered or discontinued in this setting is limited.

After a 4-week screening and run-in period, eligible participants receiving stable mavacamten and beta-blocker therapy will be randomized 1:1 to either sequential beta-blocker tapering and discontinuation or maintenance of the baseline stable beta-blocker dose. In the sequential tapering group, the daily beta-blocker dose will be reduced by approximately 25% of the baseline daily dose every 4 weeks, with complete discontinuation planned at Week 12 in participants who continue to meet predefined clinical and hemodynamic stability criteria. Participants in the maintenance group will generally continue their baseline stable beta-blocker dose throughout the 24-week randomized follow-up period.

Clinical status, heart rate, blood pressure, left ventricular ejection fraction (LVEF), and resting and Valsalva-provoked LVOT gradients will be monitored during follow-up. Prespecified criteria for pausing dose reduction, dose re-escalation, and rescue treatment will be used to protect participant safety. Key echocardiographic assessments will be centrally evaluated by an independent core echocardiography laboratory, and major clinical events and treatment failure events will be adjudicated by an independent Clinical Endpoint Committee. An independent Data and Safety Monitoring Board will review accumulated safety data.

03

Conditions studied

  • Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords

  • Obstructive Hypertrophic Cardiomyopathy
  • Mavacamten
  • Beta-Blocker
  • Sequential Tapering and Discontinuation
  • Non-Inferiority Trial
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

  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. (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

Exclusion Criteria:

  1. Previous \<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 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 [eGFR] \<30 mL/min/1.73 m²), end-stage renal disease, or ongoing dialysis.
  8. Severe hepatic impairment ( class C), decompensated liver disease, (ALT) or aspartate aminotransferase (AST) ≥3 times the at screening, or other severe hepatic dysfunction considered by the investigator to potentially affect the safe use of mavacamten.
  9. Active , ongoing systemic anticancer therapy that may substantially interfere with study assessments, or an anticipated \<1 year because of a serious comorbid condition.
  10. Pregnancy or breastfeeding, planned pregnancy during the study, or, for participants of , inability or unwillingness to use effective .
  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.
Terms in these criteria, in plain language(10)

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.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
286 participants (estimated)

Study arms

  • Experimental
    Sequential Tapering and Discontinuation Group

    Participants will undergo sequential tapering of their baseline beta-blocker therapy. The daily beta-blocker dose will be reduced approximately every 4 weeks following a planned dose pathway of approximately 100%, 75%, 50%, 25%, and 0% of the randomization baseline daily dose. Complete discontinuation is planned at Week 12 if predefined clinical and hemodynamic stability and safety criteria are met. Dose reduction may be paused, delayed, or reversed, and rescue treatment may be initiated according to protocol-defined safety criteria.

    Drug: Beta-Blocker Sequential Tapering and Discontinuation

  • Active comparator
    Baseline Stable-Dose Maintenance Group

    Participants will continue their beta-blocker at the stable dose used at randomization throughout the 24-week randomized follow-up period, unless dose modification is clinically required because of efficacy or safety concerns according to the study protocol.

    Drug: Beta-Blocker Baseline Stable-Dose Maintenance

Interventions

  • DrugBeta-Blocker Sequential Tapering and Discontinuation

    Participants will undergo sequential tapering of their baseline beta-blocker therapy. The daily beta-blocker dose will be reduced approximately every 4 weeks following a planned dose pathway of approximately 100%, 75%, 50%, 25%, and 0% of the randomization baseline daily dose. Complete discontinuation is planned at Week 12 if predefined clinical, hemodynamic, and safety criteria are met. Dose reduction may be paused or delayed, and dose rollback or rescue treatment may be implemented according to protocol-defined criteria.

  • DrugBeta-Blocker Baseline Stable-Dose Maintenance

    Participants will continue the beta-blocker type, dosing frequency, and daily dose that were stable at randomization throughout the 24-week randomized follow-up period, unless dose modification is clinically required because of efficacy or safety concerns according to the study protocol.

06

What researchers measure

Primary outcomes

  1. Week 24 Clinical and Hemodynamic Strategy Success Rate

    Proportion of participants who maintain clinical and hemodynamic stability through Week 24 without protocol-defined treatment failure. Treatment failure is defined as the occurrence of any of the following: (1) permanent discontinuation or modification of the randomized beta-blocker management strategy, or protocol-defined rescue treatment, due to insufficient efficacy or safety concerns; (2) oHCM-related heart failure hospitalization, septal reduction therapy, or death; (3) resting LVOT peak gradient ≥30 mmHg at Week 24; (4) Valsalva-provoked LVOT peak gradient ≥50 mmHg at Week 24; (5) worsening of NYHA functional class at Week 24 compared with randomization baseline; or (6) LVEF \<50% at Week 24, or confirmed LVEF \<50% during follow-up requiring interruption, dose adjustment, or discontinuation of mavacamten according to its prescribing information or clinical practice.

    Time frame: From randomization through Week 24

Secondary outcomes

  1. Change From Baseline in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at Week 24

    Change in KCCQ Clinical Summary Score (KCCQ-CSS) from randomization baseline to Week 24. The KCCQ-CSS ranges from 0 to 100, with higher scores indicating better health status.

    Time frame: Randomization baseline to Week 24

  2. Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) at Week 24

    Change in NT-proBNP concentration from randomization baseline to Week 24.

    Time frame: Randomization baseline to Week 24

Other outcomes

  1. Proportion of Participants With Complete Beta-Blocker Discontinuation at Week 12

    Proportion of participants in the sequential tapering group who successfully complete the planned discontinuation of beta-blocker therapy by Week 12.

    Time frame: Week 12

  2. Proportion of Participants Remaining Off Beta-Blockers at Week 24

    Proportion of participants in the sequential tapering group who remain completely off beta-blocker therapy at Week 24 without resumption of beta-blocker treatment.

    Time frame: Week 24

  3. Incidence of Adverse Events (AEs)

    Number and proportion of participants experiencing at least one adverse event during the randomized follow-up period.

    Time frame: From randomization through Week 24

  4. Incidence of Serious Adverse Events (SAEs)

    Number and proportion of participants experiencing at least one serious adverse event during the randomized follow-up period.

    Time frame: From randomization through Week 24

  5. Incidence of Adverse Events of Special Interest (AESIs)

    Number and proportion of participants experiencing prespecified adverse events of special interest, including LVEF \<50%, heart failure, rebound in LVOT obstruction or related symptoms requiring resumption or dose escalation of beta-blockers, clinically significant bradycardia, hypotension, arrhythmias, syncope, and other protocol-defined safety events.

    Time frame: From randomization through Week 24

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.

Of 47 non-industry interventional studies with no phase under Cardiomyopathy, Hypertrophic, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 60. This study's planned 24 months is below that.

Counting every sponsor, half of 52 studies reached it within 52 months; a quarter within 26 and three quarters within 60.

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

Registered
Sep 8, 2026
First posted
Sep 11, 2026
StartEst.
Dec 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Sep 11, 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 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07815301
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Sep 11, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Zhouqing Huang, PhD
Contact
susiehzq@126.com
+86-577-55579281

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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