Obstructive Hypertrophic Cardiomyopathy (oHCM)Phase 4NCT07807384
Efficacy and Safety of an LVEF-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Phase 4 study testing Mavacamten in people with Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Second Affiliated Hospital of Nanchang University.
Trial summary
This study aims to evaluate whether, under a treatment strategy primarily guided by left ventricular ejection fraction (LVEF), dose up-titration in adult patients with symptomatic obstructive hypertrophic cardiomyopathy who have received Mavacamten treatment for at least 12 weeks with a stable maintenance dose (as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- What is being tested?
- Mavacamten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2026
- Phase
- Phase 4
- 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
- 1. Adult patients diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and classified as New York Heart Association (NYHA) functional class II-III. 2. Have received stable Mavacamten treatment for at least 12 weeks with a stable dose. 3. LVEF ≥ 55%.
Who cannot join
- 1. Hypertrophy caused by other systemic diseases with a clear etiology. 2. Planned use of strong CYP2C19 inhibitors, moderate to strong CYP2C19 inducers, or CYP3A4 inducers during the study. 3. Planned use of disopyramide, ranolazine, verapamil combined with beta-blockers, or diltiazem combined with beta-blockers during the study. 4. Previous intolerance to Mavacamten. 5. Severe hepatic or renal dysfunction. 6. Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of a Left Ventricular Ejection Fraction-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Open-Label Study
This study aims to evaluate whether, under a treatment strategy primarily guided by left ventricular ejection fraction (LVEF), dose up-titration in adult patients with symptomatic obstructive hypertrophic cardiomyopathy who have received Mavacamten treatment for at least 12 weeks with a stable maintenance dose (as baseline) and with LVEF ≥55% can further reduce left ventricular outflow tract (LVOT) gradient after 24 weeks of treatment. It will also assess changes in hemodynamics, clinical symptoms, cardiac structure, and function. Furthermore, the study will conduct stratified analyses based on patients' baseline resting or Valsalva-provoked LVOT gradient levels at enrollment [<30 mmHg vs. ≥30 mmHg] to explore differences in the aforementioned outcome measures among patients with different gradient levels, with the goal of providing evidence for individualized clinical dose adjustment.
- Being tested
- 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.
MavacamtenDrug
Eligible participants will undergo dose escalation at baseline from their current dose to the next higher level (once daily: 2.5 mg → 5 mg, 5 mg → 10 mg, or 10 mg → 15 mg).
At Week 4, clinical status and echocardiography will be re-evaluated, and the same dose will be maintained for the subsequent 8 weeks, unless LVEF is < 50%.
After 12 weeks of treatment at the same dose level:
If LVEF remains ≥ 55%, further dose escalation is permitted. If LVEF is between 50% and 55%, the current dose will be maintained. If LVEF is < 50%, treatment will be interrupted/discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Mavacamten | Experimental | Not described Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Valsalva Peak Left Ventricular Outflow Tract (LVOT) Pressure Gradient Assessed by Echocardiography at Week 24
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
Secondary outcomes (13)
Left Ventricular Wall Thickness
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
Left Atrial Volume Index
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
Left Ventricular Mass Index
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
The Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) includes the physical limitation and total symptom domains. Scores range from 0 to 100, where higher scores indicate better health status, fewer symptoms, and less physical limitation (a better outcome).
Measured: Baseline and Week 24
Mitral Regurgitation Severity
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
Systolic Anterior Motion
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
E/A Ratio
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
Left Ventricular Ejection Fraction
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
Left Atrial Volume Index
Measured: Baseline and Week 24
Left Ventricular Wall Thickness
Measured: Baseline and Week 24
New York Heart Association (NYHA) Functional Class
Assessed by the New York Heart Association (NYHA) Functional Classification. The classification categorizes heart failure severity into four classes: Class I (no limitation of physical activity), Class II (slight limitation), Class III (marked limitation), and Class IV (unable to carry on any physical activity without discomfort). Scores range from Class I to Class IV, where higher classes indicate worse heart failure symptoms (a worse outcome)
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
NT-proBNP
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
Myocardial troponin
Measured: Baseline, Week 4, Week 8, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (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 Second Affiliated Hospital of Nanchang 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807384
- Sponsor's protocol ID
- I-2026090
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Left Ventricular Ejection Fraction-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Open-Label Study
- ClinicalTrials.gov ID
- NCT07807384
- Acronym / sponsor ID
- I-2026090
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 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 study aims to evaluate whether, under a treatment strategy primarily guided by left ventricular ejection fraction (LVEF), dose up-titration in adult patients with symptomatic obstructive hypertrophic cardiomyopathy who have received Mavacamten treatment for at least 12 weeks with a stable maintenance dose (as baseline) and with LVEF ≥55% can further reduce left ventricular outflow tract (LVOT) gradient after 24 weeks of treatment. It will also assess changes in hemodynamics, clinical symptoms, cardiac structure, and function. Furthermore, the study will conduct stratified analyses based on patients' baseline resting or Valsalva-provoked LVOT gradient levels at enrollment [<30 mmHg vs. ≥30 mmHg] to explore differences in the aforementioned outcome measures among patients with different gradient levels, with the goal of providing evidence for individualized clinical dose adjustment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mavacamten | Experimental | Drug: Mavacamten |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adult patients diagnosed with obstructive hypertrophic cardiomyopathy (HCM) and classified as New York Heart Association (NYHA) functional class II-III. 2. Have received stable Mavacamten treatment for at least 12 weeks with a stable dose. 3. LVEF ≥ 55%.
Key exclusion criteria (1 listed)
- 1. Hypertrophy caused by other systemic diseases with a clear etiology. 2. Planned use of strong CYP2C19 inhibitors, moderate to strong CYP2C19 inducers, or CYP3A4 inducers during the study. 3. Planned use of disopyramide, ranolazine, verapamil combined with beta-blockers, or diltiazem combined with beta-blockers during the study. 4. Previous intolerance to Mavacamten. 5. Severe hepatic or renal dysfunction. 6. Pregnant or lactating women.
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 |
|---|---|---|
| MavacamtenEligible participants will undergo dose escalation at baseline from their current dose to the next higher level (once daily: 2.5 mg → 5 mg, 5 mg → 10 mg, or 10 mg → 15 mg). At Week 4, clinical status and echocardiography will be re-evaluated, and the same dose will be maintained for the subsequent 8 weeks, unless LVEF is < 50%. After 12 weeks of treatment at the same dose level: If LVEF remains ≥ 55%, further dose escalation is permitted. If LVEF is between 50% and 55%, the current dose will be maintained. If LVEF is < 50%, treatment will be interrupted/discontinued. | Drug | Mavacamten |
Primary outcome
Change From Baseline in Valsalva Peak Left Ventricular Outflow Tract (LVOT) Pressure Gradient Assessed by Echocardiography at Week 24
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
13 secondary outcomes
Left Ventricular Wall Thickness
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Left Atrial Volume Index
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Left Ventricular Mass Index
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Time frame: Baseline and Week 24
Mitral Regurgitation Severity
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Systolic Anterior Motion
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
E/A Ratio
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Left Ventricular Ejection Fraction
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Left Atrial Volume Index
Time frame: Baseline and Week 24
Left Ventricular Wall Thickness
Time frame: Baseline and Week 24
New York Heart Association (NYHA) Functional Class
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
NT-proBNP
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24
Myocardial troponin
Time frame: Baseline, Week 4, Week 8, Week 12, and 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 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)
RecruitingObservational study
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Enrolling by invitationPhase 2/3
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mavacamten in people with Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Second Affiliated Hospital of Nanchang University.
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 1 inclusion and 1 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 8 Sep 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ping Li (0791-86300545, lipingsydeny@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Valsalva Peak Left Ventricular Outflow Tract (LVOT) Pressure Gradient Assessed by Echocardiography at Week 24 (time frame: Baseline, Week 4, Week 8, Week 12, and 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 8 Sep 2026.