New heart drug mavacamten tested in indian patients
NCT ID NCT07004972
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests the drug mavacamten in 50 adults in India who have a condition where the heart muscle is too thick and blocks blood flow, causing symptoms like shortness of breath and chest pain. The goal is to see if the drug is safe and works well. Participants will take the drug and be monitored for side effects and heart-related events.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mavacamten
- What this could lead to
- If successful, this could provide a new treatment option for people in India with this heart condition, potentially improving symptoms and reducing hospitalizations.
- What could go wrong
- This is a small, single-arm, open-label study with no placebo group, so results may be less reliable. Side effects are possible, and the drug may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2025
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Symptomatic obstructive hypertrophic cardiomyopathy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Laxmipat Singhania Institute of Cardiology
Kanpur, Uttar Pradesh, 208002, India
-
Local Institution - 0001
Kottayam, Kerala, 686016, India
-
Local Institution - 0002
Ernākulam, Kerala, 682041, India
-
Local Institution - 0003
Chennai, Tamil Nadu, 600002, India
-
Local Institution - 0004
Belagavi, Karnataka, 590010, India
-
Local Institution - 0005
New Delhi, National Capital Territory of Delhi, 110060, India
-
Local Institution - 0006
Surat, Gujarat, 395001, India
-
Local Institution - 0007
Bikaner, Rajasthan, 334003, India
-
Local Institution - 0008
Mangalore, Karnataka, 575007, India
-
Local Institution - 0010
Pune, Maharashtra, 411011, India
-
Local Institution - 0011
Ahmedabad, Gujarat, 380060, India
-
Local Institution - 0012
Aurangabad, Maharashtra, 431005, India
-
Local Institution - 0013
Nagpur, Maharashtra, 440015, India
-
Local Institution - 0014
Hyderabad, Andhra Pradesh, 500095, India
-
Local Institution - 0017
Kolkata, West Bengal, 700027, India
-
Local Institution - 0019
Nagpur, Maharashtra, 440022, India
-
Local Institution - 0020
Gurgaon, Haryana, 122001, India
-
Local Institution - 0021
New Delhi, National Capital Territory of Delhi, 110029, India
-
Local Institution - 0022
Aligarh, Uttar Pradesh, 202002, India
-
Local Institution - 0023
Kanpur, Uttar Pradesh, 208002, India
-
Local Institution - 0024
Nagpur, Maharashtra, 441108, India
-
Local Institution - 0025
Mumbai, Maharashtra, 400012, India
-
Local Institution - 0025
Mumbai, Maharashtra, 400022, India
-
Medanta Heart Institute
Gurgaon, Haryana, 122001, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.