2025-522475-28-00招募中3 期
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction
Tenax Therapeutics Inc.61 个研究点 分布在 8 个国家目标入组 319 人开始时间: 2026年1月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 319
- 试验地点
- 61
- 主要终点
- Efficacy: Change from baseline in 6-MWD (Day 1 to Week 26). Safety: Incidence of AEs, SAEs, physical examinations, vital signs, clinical laboratory values, ECGs, heart rate and rhythm as determined by cardiac monitoring and AESI (Day 1 to Week 26)
研究概览
简要总结
"Efficacy: Evaluate the efficacy of 26 weeks of treatment with levosimendan (TNX-103) compared with placebo in patients with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD)
Safety: To evaluate the safety and tolerability of oral levosimendan versus placebo"
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
- 否
入选标准
- •Men or women, ≥18 to 85 years of age.
- •NYHA Class II or III or ambulatory NYHA Class IV symptoms.
- •A diagnosis of WHO Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization
- •A qualifying echocardiogram performed within 45 days of Day 1 (ie within the Screening Period) showing a left ventricular ejection fraction ≥40%.
- •Documentation of the absence of pulmonary thromboembolism by ventilation-perfusion scan, computed tomography pulmonary angiogram, or pulmonary angiography performed within 45 days of Day
- •A qualifying 6-MWD of at least 100 meters, but not more than 450 meters at Screening (within 45 days of Day 1) AND at the baseline 6-Minute Walk Test (6-MWT) on Day 1.
排除标准
- •A diagnosis of PH WHO Groups 1, 3, 4, or
- •Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy.
- •Structural heart repair or replacement of the aortic valve or mitral valve within the past 24 months. OR, planned valve intervention in the next 24 months. OR, the presence of echocardiographic findings of significant valve disease as assessed from the qualifying echocardiogram and defined as: a. Mitral valve disease grade ≥3 mitral regurgitation or ≥moderate mitral stenosis. b. Aortic valve disease grade ≥2 aortic regurgitation or ≥moderate aortic stenosis
- •Any of the following clinical laboratory values within 45 days of Day 1 as specified: a. Hemoglobin <10 g/dL. b. Serum ALT or AST levels >3×ULN or total bilirubin >3×ULN. c. ECG with a heart rate-corrected QT interval using Fridericia’s formula >450 msec for males and >470 msec for females at Screening in the absence of a bundle branch block or ventricularly paced rhythm. d. Platelet count <75,000/mm
- •Any of the following structural conditions that may compromise pulmonary function: a. Congenital abnormalities of the lungs, thorax or diaphragm, that may significantly contribute to the severity of PH in the opinion of the Investigator. b. A full or partial pneumonectomy. c. Previous therapeutic radiation of lungs or mediastinum.
- •Recent documentation of significant underlying lung disease.
- •Documentation of pulmonary thromboembolism in the last 12 months by a ventilation-perfusion scan, CT pulmonary angiogram, or a pulmonary angiography with an interpretation other than a normal or low probability result.
- •Cardiovascular comorbidities, which include the following: a. Symptomatic or untreated coronary artery disease. b. Acute coronary syndrome, coronary artery bypass graft, or percutaneous coronary intervention; any within 180 days of Day
- •c. Uncontrolled resting heart rate due to atrial fibrillation or atrial flutter at the time of the Screening ambulatory cardiac monitoring. d. History of untreated serious life-threatening or hemodynamically significant arrhythmia. e. History of or anticipated heart transplant or ventricular assist device implantation. f. Anticipated implantation of a pacemaker, or pacemaker implantation within 30 days of Screening. g. Occurrence of myocardial infarction due to epicardial coronary artery disease within 180 days of Day
- •h. Uncontrolled systemic hypertension as evidenced by sitting systolic BP >170 mmHg after a period of rest during the Screening Period. i. Stroke within 90 days of Day
- •j. Systolic BP <100 mmHg at Screening and Day 1.
研究组 & 干预措施
The levosimendan placebo drug product is an immediate-release dosage form for oral administration.
Placebo
干预措施: The levosimendan placebo drug product is an immediate-release dosage form for oral administration. (Drug)
Levosimendan
Test
干预措施: Levosimendan (Drug)
结局指标
主要结局
Efficacy: Change from baseline in 6-MWD (Day 1 to Week 26). Safety: Incidence of AEs, SAEs, physical examinations, vital signs, clinical laboratory values, ECGs, heart rate and rhythm as determined by cardiac monitoring and AESI (Day 1 to Week 26)
Efficacy: Change from baseline in 6-MWD (Day 1 to Week 26). Safety: Incidence of AEs, SAEs, physical examinations, vital signs, clinical laboratory values, ECGs, heart rate and rhythm as determined by cardiac monitoring and AESI (Day 1 to Week 26)
次要结局
- 1. Change in KCCQ-TSS (Day 1 to Week 26).
- 2. Number of Clinical Worsening Events (Day 1 to Week 26). Clinical Worsening Events are defined as: a. Unplanned hospitalization due to a cardiopulmonary indication OR Urgent outpatient visits for the administration of IV diuretics. b. Deaths (caused by clinical conditions directly related to cardiovascular events).
- 3. Time to first occurrence of a Clinical Worsening Event (Day 1 to Week 26).
- 4. Change in NYHA Functional Class (Day 1 to Week 26).
研究者
Stuart Rich
Scientific
Tenax Therapeutics Inc.
研究点 (61)
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