CTRI/2025/07/091820 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On:
11/03/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A Study of Mavacamten in Adults with Obstructive Hypertrophic Cardiomyopathy in India
Scientific Title of Study
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 (ROVER)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CV0271146_ Protocol dated 01-Jul-2024
Protocol Number
NCT07004972
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Abhinav Keshwani, MBBS
Designation
Disease Area Specialist - Cardiovascular
Affiliation
Bristol-Myers Squibb India Pvt. Ltd.
Address
One International Centre, 6th Floor, Tower 1,
Senapati Bapat Marg, Elphistone (W), Mumbai- 400013
India
Mumbai MAHARASHTRA 400013 India
Phone
Fax
Email
abhinav.keshwani@bms.com
Details of Contact Person Public Query
Name
Sandip Chakraborty
Designation
Global Trial Manager
Affiliation
Bristol-Myers Squibb
Address
Ranga Reddy District, Hyderabad
Telangana,
Pin- 500 081
India
Hyderabad TELANGANA 500081 India
Phone
9959045462
Fax
Email
Sandip.chakraborty2@bms.com
Source of Monetary or Material Support
Bristol Myers Squibb India Pvt. Ltd., One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphistone (W), Mumbai 400013, India
Primary Sponsor
Name
BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED
Address
One International Centre, 6th Floor, Tower 1, Senapati Bapat Marg, Elphistone (W), Mumbai
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
BristolMyers Squibb Company
Route 206 & Province Line Road, Princeton, New Jersey, 08543
Department of Cardiology,
First floor OPD building, Room No.142, Plot No. 2, Sector 20, Sumthana, Mihan, Nagpur – 441108, Maharashtra, India. Nagpur MAHARASHTRA
09971953779
sagarmakode88@aiimsnagpur.edu.in
Dr Sandeep Seth
All India Institute of Medical Sciences
Room No. 02, 7th floor, CNC Building,Ansari Nagar, New Delhi, Delhi, India -110029 New Delhi DELHI
09650929005
drsandeepseth@hotmail.com
Dr Hisham Ahamed
Amrita Institute of Medical Sciences and Research Centre
Division: A block
Room no: 5
Dept. of Cardiology, AIMS- Ponekkara.P.O, Kochi-682041, Ernakulam KERALA
8891242684
ahamed.hisham@gmail.com
Dr Johny Joseph
Caritas Hospital & Institute of Health Sciences
Department of Research & Development Cell, Room no. 1, Thellakom P O Kottayam 686630, Kerala, India Kottayam KERALA
9447124948
drjohnyjoseph@gmail.com
Dr Anil Ramesh Jawahirani
Central India Cardiology Hospital and Research Institute
5th floor, Clinical Research room ,Plot No.1, Pioneer Co-Op Housing Society, Gawande Lay-Out, Khamla Ring Road, Opp. Sawarkar Garden, Khamla, Nagpur-440015, India Nagpur MAHARASHTRA
9822220936
anilramesh123@rediffmail.com
Dr Asit Das
IPGMER and SSKM Hospital
Department of Cardiology
Division: IPGME&R and SSKM, Kolkata
Room no: animal house 1st floor, 244, AJC Bose Road, Kolkata 700020, West Bengal, India Kolkata WEST BENGAL
09433138144
dradascard@rediffmail.com
Dr Asif Hasan
Jawaharlal Nehru Medical College and Hospital
Room No 5, OPD 14, 1st Floor, OPD BUILDING, Aligarh Muslim University, Civil Line, Aligarh -202002, Uttar Pradesh, India Aligarh UTTAR PRADESH
08923896988
asif_8796@rediffmail.com
Dr Milind Gadkari
KEM Hospital Research Centre
Diamond Jubilee Building, 5th Floor, Sardar Moodliar Road, Rasta peth, Pune - 411011, Maharashtra, India Pune MAHARASHTRA
9822030120
gadkaris@gmail.com
Dr Sanjay Porwal
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
Department of Cardiologist, OPD No. 29, 2nd Floor, Nehrunagar Belagavi-590010 Karnataka India Belgaum KARNATAKA
Ethics Committee, S.P. Medical College, Pawanpuri, Bikaner, Rajasthan, India
Approved
Ethics Committee - Caritas Hospital Caritas Hospital & Institute of Health Sciences Thellakom (PO), Kottayam, Kerala – 686630, India
Approved
Ethics Committee GSVM Medical College, Room No. 125 First Floor GSVM Medical College, Swaroop Nagar, Kanpur-208002
Approved
Ethics Committee of Care Institute Of Medical Science, Marengo CIMS Hospital. Plot no 67/1, Opp. Panchamrut Bunglows, Near Shukan Mall, Off. Science city Road, Sola, Ahmedabad 380060, Gujarat, India
Approved
IEC, KLE Academy of Higher Education & Research
Approved
Institute Ethics Committee, All India Institute of Medical Sciences, Old OT Block, Room No. 102, AIIMS Hospital Ansari Nagar, New Delhi-29 New Delhi South Delhi Delhi
Approved
Institutional Ethics Committee Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Civil Line, Aligarh -202002, Uttar Pradesh, India
Approved
Institutional Ethics Committee ,Rughwani Child Care Centre & Hospital(IEC-RCCCH) Rughwani Child Care Centre & Hospital, 22, Sindhu Nagar, Mohanlal Rughwani Marg, Jaripatka, Nagpur 440014, Maharashtra, INDIA
Approved
Institutional Ethics Committee for Clinical Trials Address: All India Institute of Medical Sciences, Plot No.2, Sector 20, 1 st Floor, OPD Building, Mihan, Nagpur – 441108, Maharashtra, India.
Institutional Ethics Committee, Amrita Institute of Medical Sciences Amrita Institute of Medical Sciences, AIMS-Ponekkara. P.O, Kochi, Edappally, Ernakulam, Kerala-682041, India
Approved
Institutional Ethics Committee-TNGMSSH, Omandurar Govt. Estate, Chennai-600002, Tamil Nadu
Approved
IPGME&R Research Oversight Committee, EC Address: Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A.J.C Bose Road, Kolkata , 700020, West Bengal, India.
Approved
KEM Hospital Research Centre Ethics Committee, 3rd Floor, TDH Building, KEM Hospital Research Centre, 489 - Rasta Peth, Sardar Moodliar Road, Pune - 411011, Maharashtra, India
The starting dose of mavacamten in this study will be 5 mg in all participants followed by individualized site read ECHO guided dose adjustments. 5 mg was chosen as the starting dose.
Mavacamten doses from 2.5 to 15 mg will be utilized in this study. 30 weeks of treatment/ duration. total duration of study up to 53 weeks.
Comparator Agent
NOT APPLICABLE
NOT APPLICABLE
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Signed Written Informed Consent
a. Participants must have signed and dated an Institutional Review Board (IRB)/Independent
Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines. This ICF must be obtained before performing any protocol related procedures that are not part of normal patient care. 2. Type of Participant and Target Disease Characteristics -a. Is able to understand and comply with the study procedures, understand the risks involved in the study, and provide informed consent according to federal, local, and institutional guidelines before the first study-specific procedure. b. Diagnosed with obstructive HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines, ie, satisfy all criteria below.i) Has unexplained LV hypertrophy with nondilated ventricular chambers in the absence of other cardiac 2. Type of Participant and Target Disease Characteristics
a. Is able to understand and comply with the study procedures, understand the risks involved
in the study, and provide informed consent according to federal, local, and institutional guidelines before the first study-specific procedure.
b. Diagnosed with obstructive HCM consistent with current American College of Cardiology Foundation or American Heart Association and European Society of Cardiology guidelines, ie, satisfy all criteria below.
i) 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 greater than or equal to 15 mm or greater than or equal to 13 mm with positive family history of hypertrophic cardiomyopathy.
c. Has LVOT peak gradient greater than or equal to 50 mmHg during screening as assessed by TTE at rest Valsalva maneuver, or post exercise LVOT peak gradient.
d Has LVOT peak gradient with Valsalva at screening TTE of greater than or equal to 30 mmHg.
e Has adequate acoustic windows to enable accurate TTEs.
f Has NYHA Class II or III symptoms at screening.
g Body weight is greater than 45 kg at screening.
h Documentation of LVEF greater than or equal to 55 percent at rest of screening TTE.
3. Age of Participant
a. Participants must be at least 18 years of age at the time of signing the ICF.
4. Reproductive Status
• The investigator shall counsel individuals of childbearing potential (IOCBP) participants (as defined in Appendix 4) on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
• The investigator or designee shall evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
• Local laws and regulations may require the use of alternative and/or additional contraceptive methods.
a. Female (as assigned at birth) participants:
i. Female (as assigned at birth) participants, who are not of childbearing potential,
must have documented proof. Note: Documentation can be obtained from the site
personnel’s review of the participant’s medical records, medical examination, or
medical history interview.
o Individuals who are not of childbearing potential (as defined in Appendix 4) are exempt from contraceptive requirements.
ii. IOCBP must have a negative highly sensitive urine and serum (at screening)
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human
chorionic gonadotropin) within 24 hours prior to the start of study intervention.
• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a
serum pregnancy test is required. In such cases, the participant must be
excluded from participation if the serum pregnancy result is positive.
• Additional requirements for pregnancy testing during and after study intervention are in Section 2: Schedule of Activities.
• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to potentially decrease the risk for inclusion of a individual with an undetected pregnancy.
iii. IOCBP must agree to follow instructions for method(s) of contraception as
described below and included in the ICF.
• IOCBP are permitted to use hormonal contraceptive methods (as described in
Appendix 4).
iv. A female (as assigned at birth) is eligible to participate if she is not pregnant or
breastfeeding and at least 1 of the following conditions applies:
• Is not an IOCBP
OR
• Is an IOCBP and using a contraceptive method that is highly effective (with a
failure rate of less than 1 percent per year), as described in Appendix 4, during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of
reproduction for the same period.
B. Male (as assigned at birth) participants:
i) No contraception requirements for male participants are mandated.
ExclusionCriteria
Details
1) Medical Conditions
a. Known infiltrative or storage disorder causing cardiac hypertrophy that mimics
obstructive hypertrophic cardiomyopathy, such as Fabry disease, amyloidosis, or Noonan
syndrome with LV hypertrophy.
b. Septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA])
within 6 months prior to screening or plans to have either of these treatments during the
study (note: individuals with an unsuccessful myectomy or percutaneous ASA procedure
performed greater than 6 months prior to screening may be enrolled if study eligibility criteria for
LVOT peak gradient criteria are met).
c. Has paroxysmal atrial fibrillation present per the investigator’s evaluation of the
participant’s ECG at the time of screening.
d. 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).
e. Has a history of syncope with exercise within 6 months prior to screening.
f. History of sustained ventricular tachyarrhythmia (greater than 30 seconds) within 6 months prior to screening.
g Implantable cardioverter-defibrillator (ICD) placement within 2 months prior to screening or planned ICD placement during the study.
h Has documented obstructive coronary artery disease (greater than 70 percent stenosis in one or more
epicardial coronary arteries) or history of myocardial infarction.
i Has known moderate or severe (as per Investigator’s judgment) aortic valve stenosis at
screening visit.
j Has participated in a clinical trial in which the participant received any investigational
drug (or is currently using an investigational device) within 30 days prior to screening or
at least 5 times the respective elimination half-life (whichever is longer). (Prior
participation in a non-interventional observational study is allowed.)
k Has a history of resuscitated sudden cardiac arrest or known history of appropriate
implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular
arrhythmia. (Note: history of anti-tachycardia pacing is allowed.)
l Has 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.
m History of clinically significant malignant disease: participants who have been
successfully treated for nonmetastatic cutaneous squamous cell or basal cell carcinoma or
have been adequately treated for cervical carcinoma in situ or breast ductal carcinoma in
situ can be included in the study.
n Is unable to comply with the study requirements, including the number of required visits to the clinical site.
o Is employed by or is a relative of someone employed by the Sponsor, the Investigator, or his/her staff or family.
2) Reproductive Status
a. Individuals who are breastfeeding
b. Individuals who are of childbearing potential
3) Prior/Concomitant Therapy
a. Inability to comply with restrictions and prohibited treatments as listed in Section 7.7:
Concomitant Therapy.
b. Is currently taking, or has taken within 14 days of screening, a prohibited medication such as a CYP2C19 inhibitor (eg, omeprazole).
c. Previous or current use of cardiac myosin inhibitor.
4) Physical and Laboratory Test Findings
a. Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG, or clinical laboratory determinations beyond what
is consistent with the target population.
b. Has any ECG abnormality considered by the Investigator to pose a risk to participant
safety (eg, second-degree atrioventricular block type II).
c. Positive urine/serum screen for drugs of abuse.
d. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit
of the laboratory reference range or total bilirubin greater than or equal to 2 times the upper limit of the laboratory
reference range.
e. Renal function less than 30% of normal for age, gender, and height as determined by the Schwartz
formula: (glomerular filtration rate GFR [mL/min/1.73m2] = [0.413 times the height (cm)] /
serum creatinine mg/dL).
f. Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or human
immunodeficiency virus (HIV)-1 and HIV-2 antibody if deemed to be clinically
significant per the determination of the Principal Investigator in conjunction with the
Sponsor Medical Monitor.
5) Allergies and Adverse Drug Reactions
a. History of allergy/hypersensitivity to any component (including excipients) of the study intervention mavacamten or related compounds.
6) Other Exclusion Criteria
a. Prisoners or participants who are involuntarily incarcerated.
b. Participation in another clinical trial concurrent with this study.
c. Any significant acute or chronic medical illness that in the opinion of the investigator
could prevent participation in the study and follow-up.
d. Inability to tolerate oral medication.
e. Inability to be venipunctured and/or tolerate venous access.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Incidence of serious Treatment Emergent Adverse Events (TEAEs)
(Number and percentage /descriptive statistics)
Baseline (Day 1) to EOS (follow up week 8 or 18 as per protocol)
Secondary Outcome
Outcome
TimePoints
Incidence of major adverse cardiac events (CV death, non-fatal stroke, non-fatal myocardial infarction, hospitalization for heart failure.
Incidence of CV hospitalizations
Incidence of heart failure (HF) events, includes HF hospitalizations andd urgent emergency room ER or outpatient visits for HF
Incidence of atrial fibrillation or flutter (new from screening)
Incidence of syncope
Incidence of non-serious AEs
Incidence of LVEF less than 50 percent
Incidence of LVEF less than 45 percent
Incidence of LVEF less than 40 percent
Incidence of LVEF less than or equal to 30 percent
Incidence of non-serious AEs
Same time frame as primary endpoint
Until the end of treatment (Week 30)
Target Sample Size
Total Sample Size="50" Sample Size from India="50" Final Enrollment numbers achieved (Total)= "50" Final Enrollment numbers achieved (India)="50"
Phase of Trial
Phase 4
Date of First Enrollment (India)
18/08/2025
Date of Study Completion (India)
Date Missing
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="2" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This Phase 4, single-arm open-label study is designed to evaluate the
safety, tolerability, and efficacy of mavacamten in participants with
symptomatic obstructive HCM in India.
Mavacamten is a first-in-class, small-molecule, selective allosteric inhibitor
of cardiac myosin adenosine triphosphatase (ATPase) specifically developed to
target the underlying pathophysiology of hypertrophic cardiomyopathy (HCM) by reducing
actin–myosin cross-bridge formation, thereby reducing contractility and
improving myocardial energetics.
In the EXPLORER-HCM (MYK-461-005) Phase 3 study, mavacamten treatment was
also effective in reducing left ventricular outflow tract (LVOT) peak gradients
and improving symptoms, exercise performance, and health status, as shown by
significant improvement in all secondary endpoints.
Main estimand for the primary objective:
Treatment: Mavacamten, Population: Adults with symptomatic obstructive
hypertrophic cardiomyopathy (HCM) in India, Variable: Incidence of serious TEAE,
Population-level summary: Percentage of participants with any serious TEAEs, Intercurrent
event (strategy): study intervention discontinuation (all serious TEAEs that
occur after last dose of study intervention +8 weeks for non-poor metabolizers
(Non-PMs) or +18 weeks for poor metabolizers [PMs] will be included in the
analysis)
Approximately 50 participants will be treated with mavacamten. It is
estimated that approximately 100 screened participants will be required to
achieve the 50 treated participants.