A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obs… (NCT07023614) | Clinical Trial Compass
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
United States165 participantsStarted 2025-10-06
Plain-language summary
FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with symptomatic nHCM
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)