Clinical trial NCT07004972: A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Symptomatic Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.


Eligibility criteria: Inclusion Criteria

* 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, Valsalva maneuver, or post exercise LVOT peak gradient.
* Has LVOT peak gradient with Valsalva 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.

Exclusion Criteria

* 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.

Primary outcomes:
measure: Incidence of serious Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 48
Secondary outcomes:
measure: Number of participants with major adverse cardiac events
timeFrame: Up to Week 48
measure: Number of participants with CV hospitalization
timeFrame: Up to Week 48
measure: Number of participants with heart failure (HF) events
timeFrame: Up to Week 48
measure: Number of participants with atrial fibrillation/flutter
timeFrame: Up to Weeks 48
measure: Number of participants with syncope
timeFrame: Up to Week 48
measure: Number of participants with left ventricular ejection fraction (LVEF) < 50%
timeFrame: Up to Week 30
measure: Number of participants with left ventricular ejection fraction (LVEF) < 45%
timeFrame: Up to Week 30
measure: Number of participants with left ventricular ejection fraction (LVEF) < 40%
timeFrame: Up to Week 30
measure: Number of participants with left ventricular ejection fraction (LVEF) < 30%
timeFrame: Up to Week 30
measure: Number of participants with non-serious AEs
timeFrame: Up to Week 48
measure: Change from baseline to Week 30 in Valsalva left ventricular outflow tract (LVOT) peak gradient
timeFrame: Up to Week 30
measure: Change from baseline to Week 30 in resting LVOT peak gradient
timeFrame: Up to Week 30
measure: Change from baseline to Week 30 in hs-troponin-I
timeFrame: Up to Week 30
measure: Change from baseline to Week 30 in N-terminal pro b-type natriuretic peptide (NT-proBNP)
timeFrame: Up to Week 30
measure: Proportion of participants with at least 1 class improvement in New York Heart Association (NYHA) functional class from baseline to Week 30
timeFrame: Up to Week 30
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Local Institution - 0014
state: Andhra Pradesh
city: New Delhi
country: India
facility: Local Institution - 0021
state: Delhi
city: New delhi
country: India
facility: Local Institution - 0005
state: Delhi
city: Ahmedabad
country: India
facility: Local Institution - 0011
state: Gujarat
city: Surat
country: India
facility: Local Institution - 0006
state: Gujarat
city: Gurgaon
country: India
facility: Local Institution - 0020
state: Haryana
city: Belagavi
country: India
facility: Local Institution - 0004
state: Karnataka
city: Mangalore
country: India
facility: Local Institution - 0008
state: Karnataka
city: Ernakulam
country: India
facility: Local Institution - 0002
state: Kerala
city: Kottayam
country: India
facility: Local Institution - 0001
state: Kerala
city: Aurangabad
country: India
facility: Local Institution - 0012
state: Maharashtra
city: Mumbai
country: India
facility: Local Institution - 0025
state: Maharashtra
city: Nagpur
country: India
facility: Local Institution - 0013
state: Maharashtra
city: Nagpur
country: India
facility: Local Institution - 0019
state: Maharashtra
city: Nagpur
country: India
facility: Local Institution - 0024
state: Maharashtra
city: Pune
country: India
facility: Local Institution - 0010
state: Maharashtra
city: Bhubaneswar
country: India
facility: Local Institution - 0016
state: Orissa
city: Cuttack
country: India
facility: Local Institution - 0018
state: Orissa
city: Ludhiana
country: India
facility: Local Institution - 0015
state: Punjab
city: Bikaner
country: India
facility: Local Institution - 0007
state: Rajasthan
city: Chennai
country: India
facility: Local Institution - 0003
state: Tamil Nadu
city: Aligarh
country: India
facility: Local Institution - 0022
state: Uttar Pradesh
city: Kanpur
country: India
facility: Local Institution - 0023
state: Uttar Pradesh
city: Kolkata
country: India
facility: Local Institution - 0017
state: WEST Bengal
city: New Delhi
country: India
facility: Local Institution - 0009
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: