NCT06215586已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 86
- 主要终点
- Change in biomarkers from Baseline to Week 12 - NT-proBNP
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with preserved ejection fraction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is an adult male or female patient ≥ 18 years of age
- •Has evidence in the medical history supporting a diagnosis of clinical HF syndrome, NYHA functional class II to III, with the duration of at least 6 months prior to the time of Screening. The HF syndrome is defined by documentation of 1 or more of the following:
- •At least 1 of the typical symptoms due to HF such as dyspnea and/or fatigue limiting exercise capacity;
- •At least 1 of the typical signs of HF such as peripheral edema, elevated jugular venous pressure, pulmonary crackles; or
- •Hospitalization, emergency department visit, or outpatient visit for HF requiring intravenous (IV) or subcutaneous (SQ) diuresis within the past 12 months.
- •Has ejection fraction (EF) >40% and left atrial enlargement by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening;
- •Has NT-proBNP level ≥ 300 pg/mL at the time of Screening. Patients with atrial fibrillation or flutter at the time of Screening are required to have an NT proBNP level of ≥500 pg/mL at the time of Screening;
- •Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgment, for a minimum of 4 weeks prior to the time of Screening and during the Screening Period, with no planned changes after randomization; Has had no addition of new guideline-directed HF therapy within the 3 months prior to the time of Screening or during the Screening Period;
排除标准
- •Has documented EF ≥ 60% by TTE within 6 months of the time of Screening or during the Screening Period;
- •Has evidence of recent HF exacerbation defined by hospitalization or requirement for IV or SQ diuretics within 60 days of the time of Screening or during the Screening Period;
- •Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration;
- •Has elective interventions (eg, percutaneous coronary intervention, device implantations, percutaneous structural heart disease interventions, cardiac and non-cardiac surgery) planned to occur during involvement in this study;
- •Has acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, or carotid angioplasty within 60 days of the time of Screening or during the Screening Period;
- •Has had a prior or planned orthotopic heart transplantation;
- •Has presence of or plan for mechanical circulatory support;
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Comparator
干预措施: Placebo (Drug)
Tovinontrine (CRD-750)
Experimental
Experimental: Tovinontrine (CRD-750)
干预措施: Tovinontrine (CRD-750) (Drug)
结局指标
主要结局
Change in biomarkers from Baseline to Week 12 - NT-proBNP
时间窗: Baseline to Week 12
The percent change in plasma NT-proBNP from Baseline to Week 12.
Change in biomarkers from Baseline to Week 12 - NT-proBNP
时间窗: Baseline to Week 12
The percent change in plasma NT-proBNP from Baseline to Week 12.
次要结局
- Change in biomarkers at week 12 by treatment group - cGMP(Baseline to Week 12)
- Change in biomarkers at week 12 by treatment group - BNP(Baseline to Week 12)
- Change in the biomarker ratio at Week 12 - NT-proBNP(Baseline to Week 12)
- Change in the biomarker ratio at Week 12 - BNP(Baseline to Week 12)
- The change from baseline in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)(Baseline to Week 12)
- The change from baseline in the KCCQ-23-CSS(Baseline to Week 12)
- New York Heart Association (NYHA) classification at Week 12(Week 12)
- Treatment Emergent Adverse Events (TEAEs)(Baseline to Week 12)
- Change in biomarkers at week 12 by treatment group - cGMP(Baseline to Week 12)
- Change in biomarkers at week 12 by treatment group - BNP(Baseline to Week 12)
- Change in the biomarker ratio at Week 12 - NT-proBNP(Baseline to Week 12)
- Change in the biomarker ratio at Week 12 - BNP(Baseline to Week 12)
- The change from baseline in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)(Baseline to Week 12)
- The change from baseline in the KCCQ-23-CSS(Baseline to Week 12)
- New York Heart Association (NYHA) classification at Week 12(Week 12)
- Treatment Emergent Adverse Events (TEAEs)(Baseline to Week 12)
研究者
研究点 (86)
Loading locations...
相似试验
已完成
2 期
A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)Heart FailureHeart Failure With Reduced Ejection FractionCardiovascular DiseasesHeart DiseasesNCT06215911Cardurion Pharmaceuticals, Inc.557
进行中（未招募）
2 期
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's DiseaseHuntington DiseaseNCT05686551Hoffmann-La Roche301
已完成
2 期
Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIVHIV InfectionsNCT00441298Centre for the AIDS Programme of Research in South Africa889
Unknown
2 期
Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)ObesityNCT00449202Manhattan Pharmaceuticals100
已完成
3 期
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal InsufficiencyRenal InsufficiencyCongestive Heart FailureNCT00709865Biogen420