A randomized, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of ninerafaxstat in patients with symptomatic non-obstructive hypertrophic cardiomyopathy
Key facts
- Where
- A Coruña, Alicante, Barcelona, Granada, L'hospitalet De Llobregat, Madrid, Majadahonda, Murcia, Palma, Salamanca, Sevilla, Valencia és Vigo, SpanyolországSee the 17 sites
- Phase
- 2. fázis
Where in Spanyolország
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpanyolországTaking people
- Hospital General Universitario Dr. BalmisAlicante, SpanyolországTaking people
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Hospital Universitario Virgen de las NievesGranada, SpanyolországTaking people
- Bellvitge University HospitalL'hospitalet De Llobregat, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- Hospital Universitario Ramón y CajalMadrid, SpanyolországTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpanyolországTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpanyolországTaking people
- Hospital Son LlatzerPalma, SpanyolországTaking people
- Hospital Universitario De SalamancaSalamanca, SpanyolországTaking people
- Hospital Universitario Virgen De La MacarenaSevilla, SpanyolországTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországTaking people
- Hospital Alvaro CunqueiroVigo, SpanyolországTaking people
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?
Trial details
- Who runs it
- Imbria Pharmaceuticals Inc.
- Trial code
- EU 2024-515125-28-00
- Record updated
- 2026. november 10.
- Original description
To evaluate the effect of ninerafaxstat compared with placebo on health status in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).Read full original descriptionShow less
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
To evaluate the effect of ninerafaxstat compared with placebo on health status in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
Inclusion: 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.
Exclusion: 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.