Obstructive Hypertrophic Cardiomyopathy (oHCM)STEP-oHCMNCT07815301
Gradual Tapering or Discontinuation of Beta-Blockers After Stabilization With Mavacamten Therapy
A study testing Beta-Blocker Sequential Tapering and Discontinuation and Beta-Blocker Baseline Stable-Dose Maintenance in people with Obstructive Hypertrophic Cardiomyopathy (oHCM), run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- What is being tested?
- Beta-Blocker Sequential Tapering and Discontinuation and Beta-Blocker Baseline Stable-Dose Maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- 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
- Age 18 to 75 years.
- Diagnosis of obstructive hypertrophic cardiomyopathy (oHCM).
- 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.
- 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.
- 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.
- Left ventricular ejection fraction (LVEF) ≥55% at randomization baseline.
- Clinically stable and considered by the investigator to be suitable for sequential tapering and discontinuation of beta-blocker therapy.
Who cannot join
- Previous LVEF <50% during mavacamten treatment, or previous interruption or discontinuation of mavacamten because of reduced left ventricular systolic function.
- 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.
- 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.
- A definite indication for beta-blocker therapy other than oHCM for which the investigator considers dose reduction or discontinuation unsafe.
- An HCM phenocopy or another disease clearly responsible for left ventricular hypertrophy, including cardiac amyloidosis, Fabry disease, or other infiltrative, storage, or metabolic cardiomyopathies.
- 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.
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- Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²), end-stage renal disease, or ongoing dialysis.
- 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.
- 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.
- Pregnancy or breastfeeding, planned pregnancy during the study, or, for participants of childbearing potential, inability or unwillingness to use effective contraception.
- 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.
- 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.
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
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 32500
Zhouqing Huang, PhD, +86-577-55579281, susiehzq@126.com
About this study
Official title: Feasibility and Safety of Sequential Tapering and Discontinuation of Beta-blockers in Patients With Obstructive Hypertrophic Cardiomyopathy After Achieving Hemodynamic Targets With Mavacamten: a Multicenter, Randomized, Open-label, Parallel-group, Non-inferiority Trial (STEP-oHCM)
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.
- Being tested
- Beta-Blocker Sequential Tapering and Discontinuation, Beta-Blocker Baseline Stable-Dose Maintenance
- Keywords
- Obstructive Hypertrophic Cardiomyopathy, Mavacamten, Beta-Blocker, Sequential Tapering and Discontinuation, Non-Inferiority Trial
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-Blocker Sequential Tapering and DiscontinuationDrug
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.
Beta-Blocker Baseline Stable-Dose MaintenanceDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Tapering and Discontinuation Group | Experimental | 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. Receives: Drug: Beta-Blocker Sequential Tapering and Discontinuation |
| Baseline Stable-Dose Maintenance Group | Active comparator | 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. Receives: Drug: Beta-Blocker Baseline Stable-Dose Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization through Week 24
Secondary outcomes (2)
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.
Measured: Randomization baseline to Week 24
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.
Measured: Randomization baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to either sequential beta-blocker tapering and discontinuation or maintenance of the baseline stable beta-blocker dose and will be followed in parallel for 24 weeks after randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815301
- Sponsor's protocol ID
- KY2026-413
- Acronym
- STEP-oHCM
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Sequential Tapering and Discontinuation of Beta-blockers in Patients With Obstructive Hypertrophic Cardiomyopathy After Achieving Hemodynamic Targets With Mavacamten: a Multicenter, Randomized, Open-label, Parallel-group, Non-inferiority Trial (STEP-oHCM)
- ClinicalTrials.gov ID
- NCT07815301
- Acronym / sponsor ID
- STEP-oHCM / KY2026-413
- Keywords
- Obstructive Hypertrophic Cardiomyopathy, Mavacamten, Beta-Blocker, Sequential Tapering and Discontinuation, Non-Inferiority Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Sep 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either sequential beta-blocker tapering and discontinuation or maintenance of the baseline stable beta-blocker dose and will be followed in parallel for 24 weeks after randomization.
| Arm | Type | Receives |
|---|---|---|
| Sequential Tapering and Discontinuation Group | Experimental | Drug: Beta-Blocker Sequential Tapering and DiscontinuationParticipants 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. |
| Baseline Stable-Dose Maintenance Group | Active comparator | Drug: Beta-Blocker Baseline Stable-Dose MaintenanceParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 75 years.
- Diagnosis of obstructive hypertrophic cardiomyopathy (oHCM).
- 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.
- 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.
- 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.
Key exclusion criteria (12 listed)
- Previous LVEF <50% during mavacamten treatment, or previous interruption or discontinuation of mavacamten because of reduced left ventricular systolic function.
- 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.
- 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.
- A definite indication for beta-blocker therapy other than oHCM for which the investigator considers dose reduction or discontinuation unsafe.
- An HCM phenocopy or another disease clearly responsible for left ventricular hypertrophy, including cardiac amyloidosis, Fabry disease, or other infiltrative, storage, or metabolic cardiomyopathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-Blocker Sequential Tapering and DiscontinuationParticipants 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. | Drug | Sequential Tapering and Discontinuation Group |
| Beta-Blocker Baseline Stable-Dose MaintenanceParticipants 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. | Drug | Baseline Stable-Dose Maintenance Group |
Primary outcome
Week 24 Clinical and Hemodynamic Strategy Success Rate
Time frame: From randomization through Week 24
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.
2 secondary outcomes
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at Week 24
Time frame: Randomization baseline to Week 24
Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) at Week 24
Time frame: Randomization baseline to Week 24
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-Blocker Sequential Tapering and Discontinuation and Beta-Blocker Baseline Stable-Dose Maintenance in people with Obstructive Hypertrophic Cardiomyopathy (oHCM), run by First Affiliated Hospital of Wenzhou Medical University 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 7 inclusion and 12 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 11 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.
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 Zhouqing Huang, PhD (+86-577-55579281, susiehzq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Week 24 Clinical and Hemodynamic Strategy Success Rate (time frame: From randomization through Week 24). 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 11 Sep 2026.