A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Microvascular endothelial function
研究概览
简要总结
The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.
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
- Double (Participant, Investigator)
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
- •Patients ≥ 18 years old.
- •Have previously undergone a Fontan Palliation.
- •Able to exercise using a supine bike.
- •Ability and willingness to provide written consent.
- •Undergoing a clinically indicated Cardiac Catheterization
排除标准
- •Patients < 18 years old.
- •Current intravenous inotropic drugs.
- •Current use of alpha-blockers, pulmonary vasodilators, or nitrates.
- •Unable to exercise.
- •Pregnancy or lactating.
- •Unable or unwilling to consent.
研究组 & 干预措施
Tadalafil Group
Study participants will receive 10 mg of Tadalafil daily for 1 week, then 20 mg daily for 1 week, and finally 40 mg daily for 50 weeks for a total therapy time of 52 weeks. Tadalafil will be taken orally in capsule form once daily.
干预措施: Tadalafil (Drug)
Placebo Group
Study participants will receive a placebo capsule that looks identical to the Tadalafil capsule. The placebo will be taken orally once daily for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Microvascular endothelial function
时间窗: 52 weeks
Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT)
Pulmonary vascular reserve
时间窗: 52 weeks
The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)
次要结局
- Renal function(52 weeks)
- Patient reported quality of life(52 weeks)
- Liver stiffness(52 weeks)
- Exercise capacity(52 weeks)
研究者
Alexander C. Egbe
Principal Investigator
Mayo Clinic