Ninerafaxstat for symptomatic non-obstructive hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

FORTITUDE-HCM is a randomized, double-blind, placebo-controlled Phase 2b trial comparing ninerafaxstat 200 mg MR to placebo on top of standard of care in patients with symptomatic non-obstructive HCM. Participants will be confirmed by core lab echocardiography and must have NYHA class II or III symptoms and a functional limitation on cardiopulmonary exercise testing. The trial measures clinical benefit and safety outcomes to determine whether ninerafaxstat improves symptoms and exercise performance versus placebo. Patients with infiltrative or other non-HCM causes of hypertrophy or who cannot perform upright exercise testing are excluded.

Why it matters

Who can join: the full rules

Select Inclusion Criteria:

* Has a clinical diagnosis of HCM consistent with current American College of Cardiology/American Heart Association and European Society of Cardiology Guideline definitions
* Has had confirmation of nHCM by the echocardiography core laboratory based on screening rest and exercise stress echocardiography
* New York Heart Association (NYHA) functional Class II or III at screening
* Functional limitation as defined by a screening CPET

Select Exclusion Criteria:

* Has a known or suspected infiltrative, genetic, or storage disorder causing cardiac hypertrophy that mimics nHCM
* Has any other condition judged by the investigator to be the primary cause of dyspnea, exercise intolerance, and/or angina
* Has an inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
* Has any medical condition that precludes upright exercise stress testing

Other protocol-defined inclusion and exclusion criteria apply.

Where it's running

• Imbria Investigational Site
  La Jolla, California, United States Recruiting
• Imbria Investigational Site
  Los Angeles, California, United States Recruiting
• Imbria Investigational Site
  San Francisco, California, United States Recruiting
• Imbria Investigational Site
  Washington D.C., District of Columbia, United States Recruiting
• Imbria Investigational Site
  Miami, Florida, United States Recruiting
• Imbria Investigational Site
  Chicago, Illinois, United States Recruiting

+26 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Medical Monitor
• Email: info@imbria.com
• Phone: (617) 675-4060

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Bisoprolol and Verapamil for treating symptoms in patients with non-obstructive hypertrophic cardiomyopathy

  This study tests whether Bisoprolol or Verapamil can help people with non-obstructive hypertrophic cardiomyopathy feel better by reducing symptoms like shortness of breath and chest pain.

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• Assessing the safety of mavacamten in Korean patients with obstructive hypertrophic cardiomyopathy

  This study is testing how safe the medication mavacamten is for adults in Korea who have symptoms of obstructive hypertrophic cardiomyopathy.

  Recruiting Bristol-Myers Squibb · Seoul and 1 other locations · NCT06146660

• Effect of mavacamten on heart blood flow in obstructive hypertrophic cardiomyopathy

  This study is testing if the medication mavacamten can improve blood flow in the hearts of people with obstructive hypertrophic cardiomyopathy after a year of treatment.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT06023186

• Registry to assess patient characteristics and outcomes in obstructive hypertrophic cardiomyopathy

  This study is trying to learn more about how people with obstructive hypertrophic cardiomyopathy are treated and what their experiences are, especially for those using the medication mavacamten.

  Recruiting at 76 sites Bristol-Myers Squibb · Anchorage, Alaska and 100 other locations · NCT05489705

• Mavacamten outcomes and real-world patient and physician experiences for obstructive HCM in the US

  See how mavacamten works and what patients and doctors experience for adults with obstructive hypertrophic cardiomyopathy treated in US community practice.

  Recruiting Bristol-Myers Squibb · Bollington, Macclesfield · NCT07557498

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.