Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

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

Keywords

Non-obstructive Hypertrophic Cardiomyopathy, nHCM, non-obstructive HCM, HCM, hypertrophic cardiomyopathy, Ninerafaxstat 200mg MR, Ninerafaxstat

Eligibility

For people ages 18 years and up

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.

Locations

  • Imbria Investigational Site accepting new patients
    San Francisco California 94143 United States
  • Imbria Investigational Site accepting new patients
    La Jolla California 92037 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Imbria Pharmaceuticals, Inc.
ID
NCT07023614
Phase
Phase 2 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 165 study participants
Last Updated