Obstructive Hypertrophic CardiomyopathyNCT06856265
Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
A study testing radiofrequency ablation and Mavacamten in people with Obstructive Hypertrophic Cardiomyopathy and Mavacamten, run by Shanghai Chest Hospital.
Trial summary
This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM). Participants were randomized into two groups: Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy, Mavacamten, Radiofrequency Ablation
- What is being tested?
- radiofrequency ablation and Mavacamten
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2025to 1 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old at screening.
- Body weight was greater than 45 kg at screening.
- Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese Society of Cardiology guidelines, ie, satisfy criteria below (criteria to be documented by the echocardiography core laboratory): A. Had unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥15 mm (or ≥13 mm with positive family history of hypertrophic cardiomyopathy), as determined by core laboratory interpretation, and B. Had left ventricular outflow tract (LVOT) peak gradient ≥50 mm Hg during screening as assessed by echocardiography at rest or after Valsalva maneuver (confirmed by echocardiography core laboratory interpretation).
- Had documented LV ejection fraction (LVEF) ≥55% by echocardiography core laboratory read of screening TTE at rest.
- Had a valid measurement of Valsalva LVOT peak gradient at screening as determined by echocardiography core laboratory.
- Had New York Heart Association (NYHA) class II or III symptoms at screening.
- Had documented oxygen saturation at rest ≥90% at screening.
- Study participants were able to understand and comply with the study procedures, understand the risks involved in the study, and provided written informed consent according to national, local, and institutional guidelines before the first study-specific procedure.
Who cannot join
- 1) Participated in a clinical trial in which the participant received any investigational drug (or was currently using an investigational device) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever was longer.
- 2) Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy. 3) Had a history of syncope within 6 months prior to screening or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
- 4) Had a history of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to screening.
- 5) Had paroxysmal, intermittent atrial fibrillation with atrial fibrillation present per the investigator's evaluation of the participant's electrocardiogram (ECG) at the time of screening.
- 6) Had persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate-controlled within 6 months prior to screening (note: participants with persistent or permanent atrial fibrillation who were anticoagulated and adequately rate-controlled were allowed).
- 7) Previously participated in a clinical study with mavacamten. 8) Hypersensitivity to any of the components of the mavacamten formulation. 9) Current treatment (within 14 days prior to screening) or planned treatment during the study with disopyramide, cibenzoline, or ranolazine. 10) Current treatment (within 14 days prior to screening) or planned treatment during the double blinded treatment with a combination of beta-blockers and verapamil or a combination of beta blockers and diltiazem.
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- 11) For individuals on beta-blockers, verapamil, or diltiazem, any dose adjustment of that medication within14 days prior to screening or any anticipated change in treatment regimen using these medications during the treatment.
- 12) Had been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to screening or planned to have either of these treatments during the study (note: individuals with an unsuccessful myectomy or percutaneous ASA procedure performed >6 months prior to screening were enrolled if study eligibility criteria for LVOT gradient criteria were met).
- 13) ICD placement within 2 months prior to screening or planned ICD placement during the study.
- 14) Had QTcF >500 msec when QRS interval <120 msec or QTcF >520 msec when QRS ≥120 msec or any other ECG abnormality considered by the investigator to pose a risk to participant safety (eg, second-degree atrioventricular block type II).
- 15) Had documented obstructive coronary artery disease (>70% stenosis in 1 or more epicardial coronary arteries) or history of myocardial infarction.
- 16) Had known moderate or severe (as per investigator's judgment) aortic valve stenosis, constrictive pericarditis, or clinically significant congenital heart disease at screening.
- 17) Had any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgment of the investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study.
- 18) Unable to comply with the study requirements, including the number of required visits to the clinical site.
- 19) Pregnant or lactating female.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mu contact
About this study
This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM).
Participants were randomized into two groups:
Read the detailed description
This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM).
Participants were randomized into two groups:
Group 1: Mavacamten monotherapy Group 2: Mavacamten + Radiofrequency Ablation
- Being tested
- radiofrequency ablation, Mavacamten
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
Radiofrequency Ablation is a minimally invasive interventional technique performed via catheter guidance. It utilizes thermal energy (50-80°C) generated by high-frequency alternating current (typically 300-750 kHz) to induce coagulative necrosis or electrophysiological isolation in targeted tissues, thereby eliminating abnormal electrical activity or mechanical obstruction. In the treatment of cardiomyopathy, RFA is applied to ablate hypertrophied myocardial tissue (e.g., the ventricular septum) to alleviate left ventricular outflow tract (LVOT) obstruction.
MavacamtenDrug
Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily.
Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations.
| Study group | Role | What they receive |
|---|---|---|
| Mavacamten monotherapy | Active comparator | Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily.
Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations.
Permitted Doses: Individualized doses included 1 mg, 2.5 mg, 5 mg, 10 mg, or 15 mg. Receives: Drug: Mavacamten |
| Mavacamten combined with radiofrequency ablation | Experimental | Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily.
Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations.
Permitted Doses: Individualized doses included 1 mg, 2.5 mg, 5 mg, 10 mg, or 15 mg.
Post-procedure Initiation: In the combination therapy group, Mavacamten was initiated within 24 hours after radiofrequency ablation. Receives: Procedure: radiofrequency ablation; Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Valsalva LVOT peak gradient from baseline to week 30, as determined by Doppler echocardiography.
Change in Valsalva LVOT peak gradient from baseline to week 30, as determined by Doppler echocardiography.
Measured: from baseline to week 30
Secondary outcomes (9)
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 30mmHg.
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 30mmHg.
Measured: At week 30
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 50 mm Hg.
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 50 mm Hg.
Measured: At week 30
The proportion of patients at week 30 at least 1 class improvement in NYHA functional classification.
The proportion of patients at week 30 at least 1 class improvement in NYHA functional classification.
Measured: Changes from baseline to week30 in the resting LVOT peak gradient
Changes from baseline to week30 in the resting LVOT peak gradient.
Changes from baseline to week30 in the resting LVOT peak gradient
Measured: from baseline to week 30
Changes from baseline to week 30 in the KCCQ Clinical Summary Score (KCCQ-CSS)
Changes from baseline to week 30 in the KCCQ Clinical Summary Score (KCCQ-CSS),
Measured: from baseline to week 30
Changes from baseline to week 30 in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level.
Changes from baseline to week 30 in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level
Measured: from baseline to week 30
Changes from baseline to week 30 in the high-sensitivity cardiac troponin I (hs-cTnI) level.
Changes from baseline to week 30 in the high-sensitivity cardiac troponin I (hs-cTnI) level.
Measured: from baseline to week 30.
Changes from baseline to week 30 left of the ventricular mass index (LVMI) evaluated by CMR imaging.
Changes from baseline to week 30 left of the ventricular mass index (LVMI) evaluated by CMR imaging.
Measured: from baseline to week 30
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Measured: from baseline to week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start26 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Trial Design: Participants were randomly assigned to two groups: Group 1: Mavacamten monotherapy Group 2: Mavacamten combined with radiofrequency ablation Dosing Protocol: Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations. Permitted Doses: Individualized doses included 1 mg, 2.5 mg, 5 mg, 10 mg, or 15 mg. Post-procedure Initiation: In the combination therapy group, Mavacamten was initiated within 24 hours after radiofrequency ablation.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856265
- Sponsor's protocol ID
- MRAHC
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 4 Mar 2025
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06856265
- Acronym / sponsor ID
- MRAHC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 26 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Mar 2025 (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 study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM).
Participants were randomized into two groups:
Detailed description
This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM).
Participants were randomized into two groups:
Group 1: Mavacamten monotherapy Group 2: Mavacamten + Radiofrequency Ablation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Trial Design: Participants were randomly assigned to two groups: Group 1: Mavacamten monotherapy Group 2: Mavacamten combined with radiofrequency ablation Dosing Protocol: Initial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations. Permitted Doses: Individualized doses included 1 mg, 2.5 mg, 5 mg, 10 mg, or 15 mg. Post-procedure Initiation: In the combination therapy group, Mavacamten was initiated within 24 hours after radiofrequency ablation.
| Arm | Type | Receives |
|---|---|---|
| Mavacamten monotherapy | Active comparator | Drug: MavacamtenInitial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations. Permitted Doses: Individualized doses included 1 mg, 2.5 mg, 5 mg, 10 mg, or 15 mg. |
| Mavacamten combined with radiofrequency ablation | Experimental | Procedure: radiofrequency ablation, Drug: MavacamtenInitial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations. Permitted Doses: Individualized doses included 1 mg, 2.5 mg, 5 mg, 10 mg, or 15 mg. Post-procedure Initiation: In the combination therapy group, Mavacamten was initiated within 24 hours after radiofrequency ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years old at screening.
- Body weight was greater than 45 kg at screening.
- Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese Society of Cardiology guidelines, ie, satisfy criteria below (criteria to be documented by the echocardiography core laboratory): A. Had unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥15 mm (or ≥13 mm with positive family history of hypertrophic cardiomyopathy), as determined by core laboratory interpretation, and B. Had left ventricular outflow tract (LVOT) peak gradient ≥50 mm Hg during screening as assessed by echocardiography at rest or after Valsalva maneuver (confirmed by echocardiography core laboratory interpretation).
- Had documented LV ejection fraction (LVEF) ≥55% by echocardiography core laboratory read of screening TTE at rest.
- Had a valid measurement of Valsalva LVOT peak gradient at screening as determined by echocardiography core laboratory.
Key exclusion criteria (15 listed)
- 1) Participated in a clinical trial in which the participant received any investigational drug (or was currently using an investigational device) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever was longer.
- 2) Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy. 3) Had a history of syncope within 6 months prior to screening or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening.
- 4) Had a history of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to screening.
- 5) Had paroxysmal, intermittent atrial fibrillation with atrial fibrillation present per the investigator's evaluation of the participant's electrocardiogram (ECG) at the time of screening.
- 6) Had persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate-controlled within 6 months prior to screening (note: participants with persistent or permanent atrial fibrillation who were anticoagulated and adequately rate-controlled were allowed).
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 |
|---|---|---|
| radiofrequency ablationRadiofrequency Ablation is a minimally invasive interventional technique performed via catheter guidance. It utilizes thermal energy (50-80°C) generated by high-frequency alternating current (typically 300-750 kHz) to induce coagulative necrosis or electrophysiological isolation in targeted tissues, thereby eliminating abnormal electrical activity or mechanical obstruction. In the treatment of cardiomyopathy, RFA is applied to ablate hypertrophied myocardial tissue (e.g., the ventricular septum) to alleviate left ventricular outflow tract (LVOT) obstruction. | Procedure or surgery | Mavacamten combined with radiofrequency ablation |
| MavacamtenInitial Dose: Both groups received a starting dose of Mavacamten 2.5 mg orally once daily. Dose Titration: Adjustments were made based on a previously published titration protocol, guided by correlations among resting left ventricular ejection fraction (LVEF), LVOT gradient during Valsalva maneuver, and pre-dose Mavacamten plasma concentrations. | Drug | Mavacamten combined with radiofrequency ablation, Mavacamten monotherapy |
Primary outcome
Change in Valsalva LVOT peak gradient from baseline to week 30, as determined by Doppler echocardiography.
Time frame: from baseline to week 30
Change in Valsalva LVOT peak gradient from baseline to week 30, as determined by Doppler echocardiography.
9 secondary outcomes
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 30mmHg.
Time frame: At week 30
The proportion of patients at week 30 with a Valsalva LVOT peak gradient less than 50 mm Hg.
Time frame: At week 30
The proportion of patients at week 30 at least 1 class improvement in NYHA functional classification.
Time frame: Changes from baseline to week30 in the resting LVOT peak gradient
Changes from baseline to week30 in the resting LVOT peak gradient.
Time frame: from baseline to week 30
Changes from baseline to week 30 in the KCCQ Clinical Summary Score (KCCQ-CSS)
Time frame: from baseline to week 30
Changes from baseline to week 30 in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level.
Time frame: from baseline to week 30
Changes from baseline to week 30 in the high-sensitivity cardiac troponin I (hs-cTnI) level.
Time frame: from baseline to week 30.
Changes from baseline to week 30 left of the ventricular mass index (LVMI) evaluated by CMR imaging.
Time frame: from baseline to week 30
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: from baseline to week 30
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 4 Mar 2025.
- 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.
Mu contact
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency ablation and Mavacamten in people with Obstructive Hypertrophic Cardiomyopathy and Mavacamten, run by Shanghai Chest Hospital.
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 8 inclusion and 15 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mu, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Valsalva LVOT peak gradient from baseline to week 30, as determined by Doppler echocardiography. (time frame: from baseline to week 30). 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 4 Mar 2025.