Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
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 5391959 California 5332921 94143 United States
  • Imbria Investigational Site accepting new patients
    La Jolla 5363943 California 5332921 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