NCT06409026已完成4 期
Effect of Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise
研究概览
简要总结
The purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •NYHA Class II-IV.
- •LVEF ≥ 40 % within the preceding year.
- •No recent initiation of pulmonary vasodilator in the last 60 days.
- •Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP <25 mm Hg).
- •Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms.
排除标准
- •Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
- •Planned coronary, carotid, or peripheral artery revascularization.
- •Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease).
- •Wheelchair bound or orthopedic inability to exercise.
- •Chronic hypoxemia with inability to exercise without oxygen supplementation.
- •Skeletal muscle myopathy.
- •History of rhabdomyolysis.
- •Participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening.
- •Receipt of any investigational medicinal product within 30 days before screening.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- •Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
- •Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
研究组 & 干预措施
Sotatercept Therapy
Experimental
All participants will receive 36 weeks of sotatercept therapy. Sotatercept is administered as a subcutaneous injection once every 3 weeks.
干预措施: Sotatercept (Drug)
结局指标
主要结局
Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise
时间窗: Baseline, Week 24
Peak exercise pulmonary arterial mean pressure/ Cardiac output (mm Hg/L/min)
次要结局
- Oxygen Consumption (VO2)(Baseline, 24 weeks)
- Pulmonary vascular resistance at peak exercise(Baseline, 24 weeks)
- Pulmonary arterial (PA) compliance at peak exercise(Baseline, 24 weeks)
- Pulmonary arterial elastance at rest(Baseline, 24 weeks)
- Pulmonary arterial elastance at peak exercise(Baseline, 24 weeks)
- Pulmonary arterial (PA) compliance at rest(Baseline, 24 weeks)
- Left ventricular (LV) transmural pressure at peak exercise(Baseline, 24 weeks)
- Single leg blood flow at peak exercise(Baseline, 24 weeks)
- Pulmonary vascular resistance at rest(Baseline, 24 weeks)
- Right Ventricular Pulmonary Artery Coupling at rest(Baseline, 24 weeks)
- Right Ventricular Pulmonary Artery Coupling at peak exercise(Baseline, 24 weeks)
- Right atrial pressure (RA) at rest(Baseline, 24 weeks)
- Right atrial pressure (RA) at peak exercise(Baseline, 24 weeks)
- Eccentricity index at peak exercise(Baseline, 24 weeks)
- Change in skeletal muscle O2 diffusive conductance (Dm) during single leg exercise(Baseline, 24 weeks)
- Left ventricular (LV) transmural pressure at rest(Baseline, 24 weeks)
- Eccentricity index at rest(Baseline, 24 weeks)
- Change in skeletal muscle O2 diffusive conductance (Dm) during peak exercise(Baseline, 24 weeks)
研究者
研究点 (2)
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