2024-515125-28-00招募中2 期
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
Imbria Pharmaceuticals Inc.40 个研究点 分布在 9 个国家目标入组 130 人开始时间: 2025年11月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 40
- 主要终点
- Change from baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).
研究概览
简要总结
To evaluate the effect of ninerafaxstat on health status in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Safety follow-Up Phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •All inclusion criteria can be found in the protocol (Section 5.1).
- •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.
排除标准
- •All exclusion criteria can be found in the protocol (Section 5.2).
- •Informed Consent: Inability or unwillingness to provide informed consent or comply with trial procedures.
- •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.
- •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.
- •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.
- •Substance Abuse: History of alcohol or substance abuse within the past year.
- •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.
- •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.
结局指标
主要结局
Change from baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).
Change from baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).
次要结局
- 1. Change in ventilatory efficiency (VE/VCO2 slope) during CPET from baseline to Week 12
- 2. Change from baseline to Week 12 in the KCCQ-TSS
- 3. Change from baseline to Week 12 in the KCCQ-PLS
- 4. Change from baseline to Week 12 in the KCCQ-OSS
- 5. Change in exercise duration during CPET from baseline to Week 12
研究者
Arash Yavari
Scientific
Imbria Pharmaceuticals Inc.
研究点 (40)
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