Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial - EMPATICC (INCOR1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Win ratio with the following 3 hierarchical components: (1) days alive and able to wash oneself, (2) ability to walk 4m, (3) self-reported patient global assessment of subjective well-being, during the 30-day placebo-controlled phase
研究概览
简要总结
The pathophysiological implications of various cancer diseases and anti-cancer therapies is the occurrence of a cardiac disease-like phenotype with cardiac dysfunction, cardiac wasting, and cardiac homeostasis changes (incl. fibrosis and apoptosis) in end-stage cancer patients, causing heart failure like syndrome with development of congestion, dyspnoea and severely reduced physical functioning. The present trial aims to evaluate, if a heart failure medication improves the self-care ability and self-reported health care status of patients with with advanced cancer receiving specialized palliative care.
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)
盲法说明
Note: We involve blinded and unblinded study investigators.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Heart failure medication arm
Combination of Sacubitril/valsartan, Ivabradine, Ferric carboxymaltose and/or Empagliflozin
干预措施: Heart failure medication (Drug)
Placebo arm
Placebo tables / infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Win ratio with the following 3 hierarchical components: (1) days alive and able to wash oneself, (2) ability to walk 4m, (3) self-reported patient global assessment of subjective well-being, during the 30-day placebo-controlled phase
时间窗: since baseline during 30 days of follow-up
The primary endpoint is analyzed using the win ratio approach, comparing patient pairs based on the hierarchy of the following 3 components: 1. The first component, "days alive and able to wash themselves," was assessed over a 30 ± 2-day period, with counts ranging from 0 to 32 days. 2. The second component, "ability to walk 4 meters," was assessed at Days 10, 20, and 30, with counts ranging from 0 to 3 visits. 3. The third component, "self-reported PGA of subjective well-being," was assessed at the last common assessment visit where both patients were alive (Day 30, 20, or 10) using a 7-point Likert scale.
次要结局
未报告次要终点