Actively Recruiting
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Led by Imbria Pharmaceuticals, Inc. · Updated on 2026-04-27
165
Participants Needed
56
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a clinical diagnosis of hypertrophic cardiomyopathy (HCM) based on current American College of Cardiology/American Heart Association and European Society of Cardiology guidelines
- Confirmation of non-obstructive hypertrophic cardiomyopathy (nHCM) by echocardiography core laboratory using rest and exercise stress echocardiography
- New York Heart Association (NYHA) functional Class II or III at screening
- Functional limitation demonstrated by a screening cardiopulmonary exercise test (CPET)
You will not qualify if you...
- Known or suspected infiltrative, genetic, or storage disorder causing cardiac hypertrophy that mimics nHCM
- Any other condition deemed by the investigator as the main cause of dyspnea, exercise intolerance, or angina
- Inability to exercise on a treadmill or bicycle due to orthopedic or other limitations
- Any medical condition preventing upright exercise stress testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 56 locations
1
Imbria Investigational Site
La Jolla, California, United States, 92037
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2
Imbria Investigational Site
Los Angeles, California, United States, 90048
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3
Imbria Investigational Site
San Francisco, California, United States, 94143
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4
Imbria Investigational Site
Washington D.C., District of Columbia, United States, 20010
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5
Imbria Investigational Site
Miami, Florida, United States, 33136
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6
Imbria Investigational Site
Chicago, Illinois, United States, 60611
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7
Imbria Investigational Site
Boston, Massachusetts, United States, 02114
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8
Imbria Investigational Site
Burlington, Massachusetts, United States, 01805
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9
Imbria Investigational Site
Grand Rapids, Michigan, United States, 49503
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10
Imbria Investigational Site
Rochester, Minnesota, United States, 55905
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11
Imbria Investigational Site
St Louis, Missouri, United States, 63110
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12
Imbria Investigational Site
New York, New York, United States, 10016
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13
Imbria Investigational Site
Charlotte, North Carolina, United States, 28204
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14
Imbria Investigational Site
Portland, Oregon, United States, 97239
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15
Imbria Investigational Site
Philadelphia, Pennsylvania, United States, 19104
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16
Imbria Investigational Site
Houston, Texas, United States, 77030
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17
Imbria Investigational Site
Plano, Texas, United States, 75093
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18
Imbria Investigational Site
Charlottesville, Virginia, United States, 22903
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19
Imbria Investigational Site
Graz, Austria, 8036
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20
Imbria Investigational Site
Edegem, Belgium, 2650
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21
Imbria Investigational Site
Montpellier, France, 34090
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22
Imbria Investigational Site
Paris, France, 75015
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23
Imbria Investigational Site
Saint-Herblain, France, 44800
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24
Imbria Investigational Site
Bad Oeynhausen, Germany, 32545
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25
Imbria Investigational Site
Göttingen, Germany, 37075
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26
Imbria Investigational Site
Heidelberg, Germany, 69120
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27
Imbria Investigational Site
Florence, Italy, 50134
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28
Imbria Investigational Site
Milan, Italy, 20131
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29
Imbria Investigational Site
Naples, Italy, 80131
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30
Imbria Investigational Site
Amsterdam-Zuidoost, Netherlands, 1105 AZ
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31
Imbria Investigational Site
Rotterdam, Netherlands, 3015 GD
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32
Imbria Investigational Site
Katowice, Poland, 40-555
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33
Imbria Investigational Site
Warsaw, Poland, 02-507
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34
Imbria Investigational Site
Wroclaw, Poland, 50-981
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35
Imbria Investigational Site
Guimarães, Portugal, 4835-044
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36
Imbria Investigational Site
Lisbon, Portugal, 1169-024
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37
Imbria Investigational Site
Lisbon, Portugal, 1500-650
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38
Imbria Investigational Site
Barcelona, Barcelona, Spain, 08035
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39
Imbria Investigational Site
A Coruña, Galicia, Spain, 15006
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40
Imbria Investigational Site
Madrid, Madrid, Spain, 28034
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41
Imbria Investigational Site
Vigo, Pontevedra, Spain, 36312
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42
Imbria Investigational Site
Seville, Sevilla, Spain, 41009
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43
Imbria Investigational Site
Seville, Sevilla, Spain, 41013
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44
Imbria Investigational Site
Barcelona, Spain, 8036
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45
Imbria Investigational Site
Barcelona, Spain, 8041
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46
Imbria Investigational Site
Barcelona, Spain, 8907
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47
Imbria Investigational Site
El Palmar, Spain, 30120
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48
Imbria Investigational Site
Madrid, Spain, 28034
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49
Imbria Investigational Site
Palma de Mallorca, Spain, 7198
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50
Imbria Investigational Site
Salamanca, Spain, 37007
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51
Imbria Investigational Site
Valencia, Spain, 46009
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52
Imbria Investigational Site
Valencia, Spain, 46009
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53
Imbria Investigational Site
London, England, United Kingdom, W12 0HS
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54
Imbria Investigational Site
Glasgow, Scotland, United Kingdom, G51 4TF
Actively Recruiting
55
Imbria Investigational Site
London, United Kingdom, 401109
Actively Recruiting
56
Imbria Investigational Site
London, United Kingdom, EC1A 7BE
Actively Recruiting
Research Team
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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