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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
CIMS Hospital
RECRUITING
Ahmedabad
Local Institution - 0022
NOT_YET_RECRUITING
Aligarh
ORIION Citicare Superspeciality Hospital
RECRUITING
Aurangabad
KLES Dr. Prabhakar Kore Hospital & M.R.C
RECRUITING
Belagavi
Local Institution - 0016
NOT_YET_RECRUITING
Bhubaneswar
Sardar Patel Medical College And Assoc. Group Of Hospitals
RECRUITING
Bikaner
Tamil Nadu Government Multi-Super-Specialty Hospital
RECRUITING
Chennai
Local Institution - 0018
WITHDRAWN
Cuttack
Amrita Hospital
RECRUITING
Ernākulam
Medanta Heart Institute
RECRUITING
Gurgaon
Osmania General Hospital
RECRUITING
Hyderabad
Laxmipat Singhania Institute of Cardiology
RECRUITING
Kanpur
Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
RECRUITING
Kolkata
Local Institution - 0001
NOT_YET_RECRUITING
Kottayam
Local Institution - 0015
NOT_YET_RECRUITING
Ludhiana
Omega Hospital
RECRUITING
Mangalore
Local Institution - 0025
NOT_YET_RECRUITING
Mumbai
Local Institution - 0025
NOT_YET_RECRUITING
Mumbai
All India Institute of Medical Sciences
RECRUITING
Nagpur
Central India cardiology hospital and Research Ins
RECRUITING
Nagpur
Local Institution - 0024
NOT_YET_RECRUITING
Nagpur
Viveka Hospital
RECRUITING
Nagpur
Local Institution - 0009
NOT_YET_RECRUITING
New Delhi
Local Institution - 0021
NOT_YET_RECRUITING
New Delhi
Sir Ganga Ram Hospital
RECRUITING
New Delhi
KEM Hospital Research Centre
RECRUITING
Pune
Unicare Heart Institute (A division of Unique Hospital)
RECRUITING
Surat
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2025-09-04
Estimated Completion Date: 2027-12-13
Participants
Target number of participants: 50
Treatments
Experimental: Mavacamten
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov