A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)

NCT07004972 | Active Not Recruiting Phase 4

• 2 other identifiers: CV027-11462025/07/091820
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 24

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.

Conditions

Symptomatic Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Incidence of serious Treatment Emergent Adverse Events (TEAEs)

  Up to Week 48

Secondary Outcomes (15)

• Number of participants with major adverse cardiac events

  Up to Week 48

• Number of participants with CV hospitalization

  Up to Week 48

• Number of participants with heart failure (HF) events

  Up to Week 48

• Number of participants with atrial fibrillation/flutter

  Up to Weeks 48

• Number of participants with syncope

  Up to Week 48

Study Arms (1)

Mavacamten

EXPERIMENTAL

Drug: Mavacamten

Interventions

Mavacamten DRUG

Specified dose on specified days

Also known as: BMS-986427

Mavacamten

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (24)

Local Institution - 0014

Hyderabad, Andhra Pradesh, 500095, India

Location

Local Institution - 0011

Ahmedabad, Gujarat, 380060, India

Location

Local Institution - 0006

Surat, Gujarat, 395001, India

Location

Local Institution - 0020

Gurgaon, Haryana, 122001, India

Location

Medanta Heart Institute

Gurgaon, Haryana, 122001, India

Location

Local Institution - 0004

Belagavi, Karnataka, 590010, India

Location

Local Institution - 0008

Mangalore, Karnataka, 575007, India

Location

Local Institution - 0002

Ernākulam, Kerala, 682041, India

Location

Local Institution - 0001

Kottayam, Kerala, 686016, India

Location

Local Institution - 0012

Aurangabad, Maharashtra, 431005, India

Location

Local Institution - 0025

Mumbai, Maharashtra, 400012, India

Location

Local Institution - 0025

Mumbai, Maharashtra, 400022, India

Location

Local Institution - 0013

Nagpur, Maharashtra, 440015, India

Location

Local Institution - 0019

Nagpur, Maharashtra, 440022, India

Location

Local Institution - 0024

Nagpur, Maharashtra, 441108, India

Location

Local Institution - 0010

Pune, Maharashtra, 411011, India

Location

Local Institution - 0021

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Local Institution - 0005

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Local Institution - 0007

Bikaner, Rajasthan, 334003, India

Location

Local Institution - 0003

Chennai, Tamil Nadu, 600002, India

Location

Local Institution - 0022

Aligarh, Uttar Pradesh, 202002, India

Location

Laxmipat Singhania Institute of Cardiology

Kanpur, Uttar Pradesh, 208002, India

Location

Local Institution - 0023

Kanpur, Uttar Pradesh, 208002, India

Location

Local Institution - 0017

Kolkata, West Bengal, 700027, India

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

MYK-461

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): December 13, 2027
• Study Completion (Estimated): December 13, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IN (24)