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New heart drug mavacamten tested in indian patients

NCT ID NCT07004972

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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