ClinicaliQ Trial Snapshot
- A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy — Recruiting • Phase II • Cardiology / Cardiovascular • NCT07023614.
- What is being tested: Ninerafaxstat, a novel therapeutic agent, is being evaluated for efficacy and safety in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) as an add-on to standard care in a double-blind, placebo-controlled Phase 2b trial.
- Patient eligibility overview: The trial targets patients with symptomatic non-obstructive HCM who remain symptomatic despite current standard of care management, representing a specific subset of the HCM population with limited treatment options.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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
Eligibility Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.