Symptomatic Obstructive Hypertrophic CardiomyopathyPhase 4NCT07004972
A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
A Phase 4 study testing Mavacamten in people with Symptomatic Obstructive Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 24 sites in India.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- Mavacamten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 24 sitesIndia
- Study dates
- 4 Sep 2025to 13 Dec 2027
- 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
- Diagnosed with obstructive hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines.
- Has unexplained LV hypertrophy with nondilated ventricular chambers in the absence of other cardiac (ie, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy).
- Has LVOT (Valsalva left ventricular outflow tract) peak gradient ≥ 50 mmHg during screening as assessed by TTE at rest or with Valsalva maneuver.
- Has LVOT peak gradient with Valsalva maneuver at screening TTE of ≥ 30 mmHg.
- Has adequate acoustic windows to enable accurate TTEs.
- Has New York Heart Association (NYHA) Class II or III symptoms at screening.
- Body weight is greater than 45 kg at screening.
- Documentation of LVEF ≥ 55% at rest of screening TTE.
Who cannot join
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics obstructive hypertrophic cardiomyopathy, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
- Has paroxysmal atrial fibrillation present per the investigator's evaluation of the participant's ECG at the time of screening.
- Has 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 are anticoagulated and adequately rate-controlled are allowed).
- Has a history of syncope with exercise within 6 months prior to screening.
- History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening.
- Has documented obstructive coronary artery disease (> 70% stenosis in one or more epicardial coronary arteries) or history of myocardial infarction.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
India24 sites
Local Institution - 0011
Ahmedabad, Gujarat, 380060
Local Institution - 0022
Aligarh, Uttar Pradesh, 202002
Local Institution - 0004
Belagavi, Karnataka, 590010
Local Institution - 0007
Bikaner, Rajasthan, 334003
Local Institution - 0003
Chennai, Tamil Nadu, 600002
Local Institution - 0012
Chhatrapati Sambhajinagar, Maharashtra, 431005
Local Institution - 0002
Ernākulam, Kerala, 682041
Local Institution - 0020
Gurgaon, Haryana, 122001
Medanta Heart Institute
Gurgaon, Haryana, 122001
Local Institution - 0014
Hyderabad, Andhra Pradesh, 500095
Laxmipat Singhania Institute of Cardiology
Kanpur, Uttar Pradesh, 208002
Local Institution - 0023
Kanpur, Uttar Pradesh, 208002
Local Institution - 0017
Kolkata, West Bengal, 700027
Local Institution - 0001
Kottayam, Kerala, 686016
Local Institution - 0008
Mangalore, Karnataka, 575007
Local Institution - 0025
Mumbai, Maharashtra, 400012
Local Institution - 0025
Mumbai, Maharashtra, 400022
Local Institution - 0013
Nagpur, Maharashtra, 440015
Local Institution - 0019
Nagpur, Maharashtra, 440022
Local Institution - 0024
Nagpur, Maharashtra, 441108
Local Institution - 0021
New Delhi, National Capital Territory of Delhi, 110029
Local Institution - 0005
New Delhi, National Capital Territory of Delhi, 110060
Local Institution - 0010
Pune, Maharashtra, 411011
Local Institution - 0006
Surat, Gujarat, 395001
About this study
Official title: A Phase 4, Single-Arm, Open-Label Study to Evaluate Safety, Tolerability, and Efficacy of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy in India
The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.
- Being tested
- Mavacamten
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
Also called BMS-986427
Specified dose on specified days
| 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.
Incidence of serious Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Week 48
Secondary outcomes (15)
Number of participants with major adverse cardiac events
Major adverse cardiac events includes cardiovascular [CV] death, non-fatal stroke, nonfatal myocardial infarction and hospitalization for heart failure
Measured: Up to Week 48
Number of participants with CV hospitalization
Measured: Up to Week 48
Number of participants with heart failure (HF) events
HF includes HF related hospitalizations and urgent emergency room [ER]/outpatient visits
Measured: Up to Week 48
Number of participants with atrial fibrillation/flutter
Measured: Up to Weeks 48
Number of participants with syncope
Measured: Up to Week 48
Number of participants with left ventricular ejection fraction (LVEF) < 50%
Measured: Up to Week 30
Number of participants with left ventricular ejection fraction (LVEF) < 45%
Measured: Up to Week 30
Number of participants with left ventricular ejection fraction (LVEF) < 40%
Measured: Up to Week 30
Number of participants with left ventricular ejection fraction (LVEF) < 30%
Measured: Up to Week 30
Number of participants with non-serious AEs
Measured: Up to Week 48
Change from baseline to Week 30 in Valsalva left ventricular outflow tract (LVOT) peak gradient
Measured: Up to Week 30
Change from baseline to Week 30 in resting LVOT peak gradient
Measured: Up to Week 30
Change from baseline to Week 30 in hs-troponin-I
Measured: Up to Week 30
Change from baseline to Week 30 in N-terminal pro b-type natriuretic peptide (NT-proBNP)
Measured: Up to Week 30
Proportion of participants with at least 1 class improvement in New York Heart Association (NYHA) functional class from baseline to Week 30
The New York Heart Association (NYHA) functional classification of heart failure assigns participants to 1 of 4 categories based on the participant's symptoms. Heart failure classification will be assessed by the Investigator at specified timepoints in the study. NYHA class at Week 30 will be compared to baseline and the proportion of participants with an improvement of at least one class will be determined.
Measured: Up 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 Jun 2025
- Study start4 Sep 2025
- Primary completion13 Dec 2027 (estimated)
- Study completion13 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004972
- Sponsor's protocol ID
- CV027-1146
- Other IDs
- 2025/07/091820
- Status last verified
- Apr 2026
- First submitted
- 26 May 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Single-Arm, Open-Label Study to Evaluate Safety, Tolerability, and Efficacy of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy in India
- ClinicalTrials.gov ID
- NCT07004972
- Acronym / sponsor ID
- CV027-1146
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 13 Dec 2027 (estimated)
- Study completion
- 13 Dec 2027 (estimated)
- First posted
- 4 Jun 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.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.
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 (8 listed)
- Diagnosed with obstructive hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines.
- Has unexplained LV hypertrophy with nondilated ventricular chambers in the absence of other cardiac (ie, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy).
- Has LVOT (Valsalva left ventricular outflow tract) peak gradient ≥ 50 mmHg during screening as assessed by TTE at rest or with Valsalva maneuver.
- Has LVOT peak gradient with Valsalva maneuver at screening TTE of ≥ 30 mmHg.
- Has adequate acoustic windows to enable accurate TTEs.
Key exclusion criteria (7 listed)
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics obstructive hypertrophic cardiomyopathy, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
- Has paroxysmal atrial fibrillation present per the investigator's evaluation of the participant's ECG at the time of screening.
- Has 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 are anticoagulated and adequately rate-controlled are allowed).
- Has a history of syncope with exercise within 6 months prior to screening.
- History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening.
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 |
|---|---|---|
| MavacamtenAlso: BMS-986427Specified dose on specified days | Drug | Mavacamten |
Primary outcome
Incidence of serious Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 48
15 secondary outcomes
Number of participants with major adverse cardiac events
Time frame: Up to Week 48
Number of participants with CV hospitalization
Time frame: Up to Week 48
Number of participants with heart failure (HF) events
Time frame: Up to Week 48
Number of participants with atrial fibrillation/flutter
Time frame: Up to Weeks 48
Number of participants with syncope
Time frame: Up to Week 48
Number of participants with left ventricular ejection fraction (LVEF) < 50%
Time frame: Up to Week 30
Number of participants with left ventricular ejection fraction (LVEF) < 45%
Time frame: Up to Week 30
Number of participants with left ventricular ejection fraction (LVEF) < 40%
Time frame: Up to Week 30
Number of participants with left ventricular ejection fraction (LVEF) < 30%
Time frame: Up to Week 30
Number of participants with non-serious AEs
Time frame: Up to Week 48
Change from baseline to Week 30 in Valsalva left ventricular outflow tract (LVOT) peak gradient
Time frame: Up to Week 30
Change from baseline to Week 30 in resting LVOT peak gradient
Time frame: Up to Week 30
Change from baseline to Week 30 in hs-troponin-I
Time frame: Up to Week 30
Change from baseline to Week 30 in N-terminal pro b-type natriuretic peptide (NT-proBNP)
Time frame: Up to Week 30
Proportion of participants with at least 1 class improvement in New York Heart Association (NYHA) functional class from baseline to Week 30
Time frame: Up 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 28 Apr 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Related trials for Symptomatic Obstructive Hypertrophic Cardiomyopathy
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Non-obstructive Hypertrophic Cardiomyopathy
Active, not recruitingPhase 3
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
Enrolling by invitationPhase 2/3
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
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BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
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Active, not recruitingObservational study
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Hypertrophic Cardiomyopathy (HCM)
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. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mavacamten in people with Symptomatic Obstructive Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 24 sites in India.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in India. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Week 48). 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 28 Apr 2026.