Recruiting NCT07023614
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ninerafaxstat 200mg MR, Placebo.
- Who it may be relevant to
- Registry conditions: Non-obstructive Hypertrophic Cardiomyopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, France, Germany +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Drug Ninerafaxstat 200mg MR
Ninerafaxstat 200mg Modified Release tablet administered BID - Drug Placebo
Matching placebo tablet administered BID
Primary outcome measures
- Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) [Time frame: Baseline to Week 12]
Secondary outcome measures (4)
- Change in ventilatory efficiency (VE/VCO2 slope) during cardiopulmonary exercise testing (CPET) [Time frame: Baseline to Week 12]
- Change in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) [Time frame: Baseline to Week 12]
- Change in the Kansas City Cardiomyopathy Questionnaire Physical Limitations Score (KCCQ-PLS) [Time frame: Baseline to Week 12]
- Change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) [Time frame: Baseline to Week 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 22 centers
- Imbria Investigational Site — La Jolla
- Imbria Investigational Site — Los Angeles
- Imbria Investigational Site — San Francisco
- Imbria Investigational Site — Washington D.C.
- Imbria Investigational Site — Miami
- Imbria Investigational Site — Chicago
- Imbria Investigational Site — Oak Lawn
- Imbria Investigational Site — Baltimore
- … and 14 more centers
Spain · 15 centers
- Imbria Investigational Site — Barcelona
- Imbria Investigational Site — A Coruña
- Imbria Investigational Site — Madrid
- Imbria Investigational Site — Vigo
- Imbria Investigational Site — Seville
- Imbria Investigational Site — Seville
- Imbria Investigational Site — Barcelona
- Imbria Investigational Site — Barcelona
- … and 7 more centers
Italy · 6 centers
- Imbria Investigational Site — Florence
- Imbria Investigational Site — Massa
- Imbria Investigational Site — Milan
- Imbria Investigational Site — Milan
- Imbria Investigational Site — Milan
- Imbria Investigational Site — Naples
United Kingdom · 5 centers
- Imbria Investigational Site — London
- Imbria Investigational Site — Glasgow
- Imbria Investigational Site — London
- Imbria Investigational Site — London
- Imbria Investigational Site — Oxford
Germany · 4 centers
- Imbria Investigational Site — Bad Oeynhausen
- Imbria Investigational Site — Göttingen
- Imbria Investigational Site — Heidelberg
- Imbria Investigational Site — Jena
Netherlands · 4 centers
- Imbria Investigational Site — Amsterdam-Zuidoost
- Imbria Investigational Site — Leiden
- Imbria Investigational Site — Nijmegen
- Imbria Investigational Site — Rotterdam
France · 3 centers
- Imbria Investigational Site — Montpellier
- Imbria Investigational Site — Paris
- Imbria Investigational Site — Saint-Herblain
Poland · 3 centers
- Imbria Investigational Site — Katowice
- Imbria Investigational Site — Warsaw
- Imbria Investigational Site — Wroclaw
Portugal · 3 centers
- Imbria Investigational Site — Guimarães
- Imbria Investigational Site — Lisbon
- Imbria Investigational Site — Lisbon
Austria · 1 center
- Imbria Investigational Site — Graz
Belgium · 1 center
- Imbria Investigational Site — Edegem
Identifiers
NCT: NCT07023614 · IMB101-010