A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of a Single Dose of 1 mg Riociguat (BAY63-2521) on Myocardial Contractility and Relaxation in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction (PH-sLVD)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 1
- 主要终点
- Change in Peak Power Index at Rest
研究概览
简要总结
The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction
详细描述
Adverse event data will be covered in Adverse events section.
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
- •Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite standard heart failure therapy
排除标准
- •Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
研究组 & 干预措施
Riociguat (Adempas, BAY63-2521)
Participants received a single oral dose of 1 mg riociguat.
干预措施: Riociguat (Adempas, BAY63-2521) (Drug)
Placebo
Participants received a single oral dose of 1 mg placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Peak Power Index at Rest
时间窗: Before and 1 hour after administration of study drug
The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The peak power index is calculated from the maximal power (which also takes the calculated parameter cardiac output into account) divided by the left ventricular end-diastolic volume (LVEDV). Formula: Peak Power Index = (SAPmean - PCWPmean)\*CO \[cardiac output\]\*16.667/LVEDV
次要结局
- Change in the Ventilatory Efficiency (V'E/V'CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET)(Before and 1 hour after administration of study drug)
- Change in Peak Power Index During the Cardiopulmonary Exercise Tests(Before and 1 hour after administration of study drug)
- Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests(Before and 1 hour after administration of study drug)
- Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests(Before and 1 hour after administration of study drug)
- Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests(Before and 1 hour after administration of study drug)
- Change in Left Ventricular Stroke Work Index (LVSWI) at Rest(Before and 1 hour after administration of study drug)
- Change in Left Ventricular Ejection Fraction (LVEF) at Rest(Before and 1 hour after administration of study drug)
- Change in End-systolic Elastance at Rest(Before and 1 hour after administration of study drug)
- Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests(Before and 1 hour after administration of study drug)
- Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E') During the Cardiopulmonary Exercise Tests(Before and 1 hour after administration of study drug)