A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Condition(s) studied
Investigational drug(s) / intervention(s)
Ninerafaxstat 200mg MR: Ninerafaxstat 200mg Modified Release tablet administered BID
Placebo: Matching placebo tablet administered BID
Study 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
Eligibility
Primary outcome measure(s)
- Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) — Baseline to Week 12
The Clinical Summary Score is a merging of symptom frequency and symptom burden domains into a total symptom score combined with the physical limitation domain. Scoring ranges from 0 to 100, with higher scores indicating better health status.
Trial sites (67)
| Facility | City | Region | Status |
|---|---|---|---|
| Imbria Investigational Site | La Jolla | California | Recruiting |
| Imbria Investigational Site | Los Angeles | California | Recruiting |
| Imbria Investigational Site | San Francisco | California | Recruiting |
| Imbria Investigational Site | Washington D.C. | District of Columbia | Recruiting |
| Imbria Investigational Site | Miami | Florida | Recruiting |
| Imbria Investigational Site | Chicago | Illinois | Recruiting |
| Imbria Investigational Site | Oak Lawn | Illinois | Not Yet Recruiting |
| Imbria Investigational Site | Baltimore | Maryland | Recruiting |
| Imbria Investigational Site | Boston | Massachusetts | Recruiting |
| Imbria Investigational Site | Burlington | Massachusetts | Recruiting |
| Imbria Investigational Site | Grand Rapids | Michigan | Recruiting |
| Imbria Investigational Site | Rochester | Minnesota | Recruiting |
| Imbria Investigational Site | St Louis | Missouri | Recruiting |
| Imbria Investigational Site | New York | New York | Recruiting |
| Imbria Investigational Site | Charlotte | North Carolina | Recruiting |
| Imbria Investigational Site | Portland | Oregon | Recruiting |
| Imbria Investigational Site | Philadelphia | Pennsylvania | Recruiting |
| Imbria Investigational Site | Philadelphia | Pennsylvania | Recruiting |
| Imbria Investigational Site | Houston | Texas | Recruiting |
| Imbria Investigational Site | Plano | Texas | Recruiting |
| Imbria Investigational Site | Charlottesville | Virginia | Recruiting |
| Imbria Investigational Site | Richmond | Virginia | Recruiting |
| Imbria Investigational Site | Graz | Austria | Recruiting |
| Imbria Investigational Site | Edegem | Belgium | Recruiting |
| Imbria Investigational Site | Montpellier | France | Recruiting |
| Imbria Investigational Site | Paris | France | Recruiting |
| Imbria Investigational Site | Saint-Herblain | France | Recruiting |
| Imbria Investigational Site | Bad Oeynhausen | Germany | Recruiting |
| Imbria Investigational Site | Göttingen | Germany | Recruiting |
| Imbria Investigational Site | Heidelberg | Germany | Recruiting |
| Imbria Investigational Site | Jena | Germany | Not Yet Recruiting |
| Imbria Investigational Site | Florence | Italy | Recruiting |
| Imbria Investigational Site | Massa | Italy | Recruiting |
| Imbria Investigational Site | Milan | Italy | Recruiting |
| Imbria Investigational Site | Milan | Italy | Recruiting |
| Imbria Investigational Site | Milan | Italy | Recruiting |
| Imbria Investigational Site | Naples | Italy | Recruiting |
| Imbria Investigational Site | Amsterdam-Zuidoost | Netherlands | Recruiting |
| Imbria Investigational Site | Leiden | Netherlands | Not Yet Recruiting |
| Imbria Investigational Site | Nijmegen | Netherlands | Not Yet Recruiting |
+ 27 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07023614 on ClinicalTrials.gov ↗ ← All trials in Spain