A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy

  • STATUS
    Recruiting
  • End date
    Dec 16, 2024
  • participants needed
    100
  • sponsor
    MyoKardia, Inc.
Updated on 16 September 2021

Summary

This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (oHCM [also known as HOCM]) who are eligible for SRT based on ACCF/AHA 2011 and/or ESC 2014 guidelines.

Details
Condition Hypertrophic Cardiomyopathy, hypertrophic obstructive cardiomyopathy
Treatment Placebo, mavacamten
Clinical Study IdentifierNCT04349072
SponsorMyoKardia, Inc.
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 18 years old at screening and body weight > 45 kg at screening
Diagnosed with oHCM consistent with current ACCF/AHA 2011 and/or ESC 2014 guidelines and meet their recommendations for invasive therapies
Referred or under active consideration within the past 12 months for SRT procedure and willing to have SRT procedure
Has documented left ventricular ejection fraction (LVEF) 60% at Screening
Has documented oxygen saturation at rest 90% at Screening

Exclusion Criteria

Persistent or permanent atrial fibrillation and subject not on anticoagulation for 4 weeks prior to screening and/or not adequately rate controlled 6 months prior to screening
Previously treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA])
For individuals on beta blockers, calcium channel blockers, or disopyramide, any dose adjustment of these medications < 14 days prior to screening or an anticipated change in regimen during the first 16 weeks of the study
Any medical condition that precludes upright exercise stress testing
Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at screening
Prior treatment with cardiotoxic agents, such as doxorubicin or similar
Has a history or evidence of any other clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note