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 (25) 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
Local Institution - 0011
NOT_YET_RECRUITING
Ahmedabad
Local Institution - 0022
NOT_YET_RECRUITING
Aligarh
Local Institution - 0012
NOT_YET_RECRUITING
Aurangabad
KLES Dr. Prabhakar Kore Hospital & M.R.C
RECRUITING
Belagavi
Local Institution - 0016
NOT_YET_RECRUITING
Bhubaneswar
Local Institution - 0007
NOT_YET_RECRUITING
Bikaner
Local Institution - 0003
NOT_YET_RECRUITING
Chennai
Local Institution - 0018
WITHDRAWN
Cuttack
Local Institution - 0002
NOT_YET_RECRUITING
Ernākulam
Medanta Heart Institute
RECRUITING
Gurgaon
Osmania General Hospital
RECRUITING
Hyderabad
Laxmipat Singhania Institute of Cardiology
RECRUITING
Kanpur
Local Institution - 0017
NOT_YET_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 - 0013
NOT_YET_RECRUITING
Nagpur
Local Institution - 0019
NOT_YET_RECRUITING
Nagpur
Local Institution - 0024
NOT_YET_RECRUITING
Nagpur
Local Institution - 0005
NOT_YET_RECRUITING
New Delhi
Local Institution - 0009
NOT_YET_RECRUITING
New Delhi
Local Institution - 0021
NOT_YET_RECRUITING
New Delhi
Local Institution - 0010
NOT_YET_RECRUITING
Pune
Unicare Heart Institute (A division of Unique Hospital)
RECRUITING
Surat
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.