Frontlight ResearchEarly access
Taking people in GermanyPhase 2
Tests ninerafaxstat in adults with symptomatic non-obstructive hypertrophic cardiomyopathy
Compares ninerafaxstat with placebo in adults with a thickened heart muscle and symptoms.
Key facts
- Who runs it
- Imbria Pharmaceuticals Inc.
- Where
- Bad Oeynhausen, Goettingen, Heidelberg, and Jena, GermanySee the 4 sitesAlso in 8 other countries, 40 sites
- Trial code
- Registry title
- A randomized, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of ninerafaxstat in patients with symptomatic non-obstructive hypertrophic cardiomyopathy
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 130 people, planned
- Started
- 8 Dec 2025
- Expected to end
- 30 Nov 2026
- Type of study
- Interventional
- Record updated
- 10 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with symptomatic non-obstructive hypertrophic cardiomyopathy, a heart muscle thickening without a blocked outflow from the heart.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- A clinical diagnosis of hypertrophic cardiomyopathy with unexplained thickening of the left heart wall, with symptoms and no blocked outflow (non-obstructive).
- Earlier treatment
- No other investigational drugs and no other clinical trial in the 30 days before screening.
Main reasons for not taking part
- Obstructive HCM with a left ventricular outflow tract gradient of 30 mmHg or more
- Heart attack, stroke or heart surgery in the 6 months before screening
- Known hepatitis B or C or HIV infection
- Pregnant or breastfeeding women
- Alcohol or substance abuse in the past year
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- All inclusion criteria can be found in the protocol (Section 5.1). 1. Informed Consent: Able to comprehend and willing to sign an informed consent form (ICF), and willing to comply with all trial procedures and restrictions for the duration specified in the Schedule of Events. Understands the risks involved
- Age: Individual ≥18 years of age at the time of signing informed consent
- Echocardiography: Has adequate acoustic windows for echocardiography
- Clinical Diagnosis: Has a clinical diagnosis of hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology/American Heart Association and European Society of Cardiology Guideline definition, with unexplained left ventricular hypertrophy (LVH) in the absence of other cardiac or systemic diseases that can produce the magnitude of hypertrophy observed
Who cannot take part
- Cardiovascular Conditions: • History of obstructive hypertrophic cardiomyopathy (HCM) with left ventricular outflow tract (LVOT) gradient ≥30 mmHg at rest or with provocation. • History of major adverse cardiovascular events (MACE) within 6 months prior to screening, including myocardial infarction, stroke, or cardiac surgery
- Medications: • Use of disallowed medications that may interfere with the trial, such as other investigational drugs within 30 days prior to screening. • Requirement for treatment with drugs that may affect the study outcomes, such as certain antiarrhythmic or antihypertensive medications
- Other Exclusions: • Participation in another clinical trial within 30 days prior to screening. • Any condition that, in the opinion of the investigator, would make participation in the trial unsafe or otherwise not in the best interest of the participant
- Medical Conditions: • Significant comorbidities that may impact the ability to complete the trial or the interpretation of results, such as uncontrolled diabetes, severe renal impairment, or active infection. • Known history of hepatitis B or C infection, or HIV infection
- Substance Abuse: History of alcohol or substance abuse within the past year
- All exclusion criteria can be found in the protocol (Section 5.2). 1. Informed Consent: Inability or unwillingness to provide informed consent or comply with trial procedures
- Pregnancy and Lactation: • Pregnant or breastfeeding women. • Women of childbearing potential not willing to use effective contraception during the study and for a specified period after the last dose
Where in Germany
Also in 8 other countries, 40 sites
- Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet BochumBad Oeynhausen, GermanyTaking people
- Universitaetsmedizin GoettingenGoettingen, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- Universitaetsklinikum Jena KöRJena, GermanyTaking people
About the trial
What the trial wants to find out
To evaluate the effect of ninerafaxstat compared with placebo on health status in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests ninerafaxstat in adults with symptomatic non-obstructive hypertrophic cardiomyopathyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 11 November 2026.
- Record updated
- 10 November 2026