NCT06092970终止不适用
Clinical Protocol REN-007E - Extension Study: An Evaluation of Patient Reported Outcomes and Clinical Outcomes Through 12 Months Post-Cardiac Surgery in Subjects Enrolled in Study REN-007
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 353
- 试验地点
- 41
- 主要终点
- Evaluation
研究概览
简要总结
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery:
- Patient reported outcomes (PRO), using the EQ-5D questionnaire
- Clinical outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.
排除标准
- •Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study.
- •Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.
研究组 & 干预措施
Placebo
Patients undergoing CABG, valve, or combined CABG/valve surgery
干预措施: Placebo (Drug)
RBT-1
Patients undergoing CABG, valve, or combined CABG/valve surgery
干预措施: RBT-1 (Drug)
结局指标
主要结局
Evaluation
时间窗: 12 Months Post-Cardiac Surgery
To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire
次要结局
未报告次要终点
研究者
研究点 (41)
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