TranslateFORTITUDE-HCM
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. View the webinar below for more information.
ABOUT nHCM
Hypertrophic cardiomyopathy (HCM) is a condition in which the heart muscle becomes thicker than normal, making it harder for the heart to pump blood effectively.
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:
- Shortness of breath
- Chest pain (angina)
- Tiredness
- Dizziness
- A racing or irregular heartbeat (palpitations)
Symptoms vary and often get worse with physical activity. There are currently no approved treatments specifically for nHCM.
WHAT IS FORTITUDE-HCM?
Clinical Trial Overview
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.
Clinical Trial Duration
Participation in the study will last approximately 20 weeks. This includes screening, 12 weeks of treatment, and follow-up visits for all trial participants.
Clinical Trial Drug
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.
Clinical Trial Locations
FORTITUDE-HCM is enrolling participants at sites across the United States. View All Sites on ClinicalTrials.gov (NCT07023614).
To understand how well ninerafaxstat works, the study will measure things like:
- Your cardiac symptoms and how these affect your everyday activities
- Your ability to exercise (using a treadmill or bicycle up to your personal best)
- The structure and function of your heart using a heart ultrasound (echocardiogram)
- The amount of ninerafaxstat in your blood
These measurements help researchers learn whether the study drug makes a meaningful difference for people living with nHCM.
Patient Support
Scheduling:
Intake & Navigation Calls
To schedule your Intake, please click the link under each Intake Coordinator to view available times. You may select any Coordinator whose available time works for you. If you need assistance scheduling your call, please call us at 1-973-983-7429 or email support@4hcm.org.
If more than one member of your family has HCM, we require a separate Intake for each person who needs to speak with our Navigators.
If you are calling on behalf of another person and that person is old enough to report their own symptoms, we need them to join the call for just a few minutes to tell us their symptoms in their own words. If that person is over 18, we need their permission for you to speak on their behalf. If you are calling for a child, you must be the parent or legal guardian of that child, or send us written permission from the legal guardian so we can speak with you.
Is membership in your future?
Membership provides you a partner in your HCM Journey.
HCMA YouTube Archive
Faces of HCM
HCMA Tales from the Heart Podcast Archive
HCMA and Nest are partnering to make HCMA’s current and future services more easily accessible. All HCMA members will receive access to the Nest companion.
We are also working together to streamline the process of keeping your health information up-to-date so HCMA can help ensure you get the care you need.