Impact of Spironolactone on Endothelial Function in Patients With Single Ventricle Heart
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Flow Mediated Dilation
研究概览
简要总结
Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions. Using ultrasound we can see how arteries change with movement or even drugs. We want to use ultrasound to see how blood vessels look in patients with Congestive Heart Failure (CHF) and to also see how a drug called Spironolactone, commonly prescribed for patients with this disease, effects blood vessel function in patients with congestive heart failure. This information may be used to change the standard of care for patients with heart failure especially if we show that Spironolactone has a positive effect on vessel function in patients with CHF.
详细描述
Spironolactone The starting dose of spironolactone is 1 mg/kg/day. After two weeks this dose will be doubled to the same maximum dose (2/mg/kg/day) as in RALES. If side effects occur or plasma urea and electrolytes became deranged the dose will be halved. Patients unable to tolerate the minimum dose will be withdrawn. Measurement of serum electrolytes will occur at baseline, at two weeks, and at time of repeat evaluation.
Endothelial Function
Subjects with single ventricle will have an evaluation of endothelial function:
- At baseline
- On spironolactone- 4-5 weeks after initial study.
Imaging protocol:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Single Ventricle Subjects
- •>17 years
- •have undergone Fontan Procedure
排除标准
- •History of smoking
- •Diabetes mellitus
- •Renal failure (serum creatinine > 2.5 mg/dl)
- •Recovering spironolactone for maintenance therapy
- •History of hyperkalemia (serum potassium> 5.5 mEq/L)
研究组 & 干预措施
Open Label
干预措施: Spironolactone (drug) (Drug)
结局指标
主要结局
Change in Flow Mediated Dilation
时间窗: Baseline, Post-Intervention (4 Weeks)
Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.
次要结局
- C-Reactive Protein Level(Baseline, Post-Intervention (4 Weeks))
- Interleukin-6 (IL-6) Level(Baseline, Post-Intervention (4 Weeks))
- Interleukin 1 Beta (IL1b) Level(Baseline, Post-Intervention (4 Weeks))
- Interleukin-10 (IL10) Level(Baseline, Post-Intervention (4 Weeks))
- Tumor Necrosis Factor-Alpha (TNF-a) Level(Baseline, Post-Intervention (4 Weeks))
- Change in 6 Minute Walk Test Score(Baseline, Post-Intervention (4 Weeks))
研究者
William T. Mahle, MD
Principal Investigator
Emory University