Ninerafaxstat in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (FORTITUDE-HCM)

Purpose of Study

What is the Purpose of this Study?

The purpose of this study is to evaluate the effects and safety of an experimental drug called ninerafaxstat in people who are experiencing symptoms from non-obstructive hypertrophic cardiomyopathy (nHCM, also called “symptomatic nHCM”). In nHCM, the heart muscle is thicker than it should be, which can affect how well the heart pumps blood. Common symptoms include shortness of breath, discomfort or tightness in the chest, feeling unusually tired, faint, or dizzy, and palpitations (racing or irregular heartbeat). Ninerafaxstat is designed to help the heart make energy more efficiently. By boosting the energy levels and efficiency of the heart, ninerafaxstat can make the heart work with less strain, which may help improve symptoms of nHCM. Study procedures include physical exams, vitals, medical history, electrocardiograms, echocardiograms, exercise stress test, imaging, and blood draws. Ninerafaxstat will be compared to placebo (inactive substance) when taken alongside the patient’s regular treatment. Participants will be randomly assigned to receive either ninerafaxstat or placebo.


Study Eligibility

Eligibility


Not Available


Study Sites

Where can I participate?



Beverly


What is the full name of this clinical trial?

A Global Phase 2b, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Study Details
Disease Type/Condition

Other

Principal Investigator
1

Rader, Florian

Age Group

Adult

Phase

II

IRB Number

STUDY00004249


How do I learn more about this study?

Email

clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Rader, Florian

Age Group

Adult

Phase

II

IRB Number

IMB101-010


Contact
Email
clinicaltrials@cshs.org