FORTITUDE-HCM is a global clinical study evaluating whether ninerafaxstat, a new investigational drug, can help adults with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) feel and function better in daily life.
In this study, participants will receive either ninerafaxstat or a placebo. A placebo looks like the study drug but has no active ingredients. Comparing the two helps researchers learn if ninerafaxstat can improve heart-related symptoms and quality of life.
These measurements help researchers learn whether the study drug makes a meaningful difference for people living with nHCM.
(Abbreviated Participation Criteria)
Additional requirements apply. Check full eligibility at ClinicalTrials.gov (NCT07023614).
FORTITUDE-HCM is a Phase 2b clinical trial studying whether ninerafaxstat, a new investigational drug, can improve symptoms, exercise capacity, and overall quality of life in adults with symptomatic nHCM.
In this study, participants are randomly assigned to take either ninerafaxstat or a placebo. Your chance of receiving either ninerafaxstat or placebo will be 1 in 2 (i.e. 50%). This helps ensure the study results are fair and unbiased.
Participation in the study will last approximately 20 weeks. This includes screening, 12 weeks of treatment, and follow-up visits for all trial participants.
If you qualify and join the study, you will receive ninerafaxstat (200 mg twice daily) or a placebo. You will continue your usual standard-of-care treatment during the study.
FORTITUDE-HCM is enrolling participants at sites across the United States. View All Sites on ClinicalTrials.gov (NCT07023614).
In non-obstructive HCM, or nHCM, the heart muscle is thickened but does not block blood flow out of the heart. Even without a blockage, the heart may not fill or relax the way it should.
People with nHCM may have symptoms such as:
Symptoms vary and often get worse with physical activity. There are currently no approved treatments specifically for nHCM.
