Testing ninerafaxstat against placebo in adults with symptomatic non-obstructive hypertrophic cardiomyopathy
Tests ninerafaxstat against a placebo in adults with symptomatic non-obstructive heart thickening.
Plain-language title generated from the registry record
Registry title: A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Key facts
- Where
- Bologna, Florence, Massa, Milan, and Naples, ItalySee the 5 sites
- Phase
- Phase 2
Where in Italy
- BolognaBologna, ItalyNot yet recruiting
- FlorenceFlorence, ItalyTaking people
- MassaMassa, ItalyTaking people
- MilanMilan, ItalyTaking people
- NaplesNaples, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Imbria Pharmaceuticals, Inc.
- Trial code
- NCT07023614
- Record updated
- 26 October 2026
- Original description
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 nHCMRead full original descriptionShow less
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 - FORTITUDE-HCM
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
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.