Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Procollagen N-terminal Peptide 1
研究概览
简要总结
Hypothesis:
By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis.
Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation
- •Patient followed regularly at Washington University-affiliated institution
- •If female, willing to use 2 forms of contraception including one barrier method during protocol
排除标准
- •GFR <30 ml/min
- •Potassium >5.0 mmol/L
- •Unable or unwilling to comply with study protocol
- •Use of potassium sparing diuretics
- •Use of an aldosterone blocker currently or previously
- •Known intolerance of eplerenone or aldosterone blockade
- •Pregnant, breastfeeding, or actively trying to get pregnant
研究组 & 干预措施
Eplerenone after drug free period
Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period
干预措施: Eplerenone (Drug)
Eplerenone before drug free period
Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period
干预措施: Eplerenone (Drug)
结局指标
主要结局
Procollagen N-terminal Peptide 1
时间窗: Baseline, 6 months and 12 months from eplerenone administration
Galectin 3
时间窗: Baseline, 6 months and 12 months from eplerenone administration
Procollagen III N-Terminal Peptide
时间窗: Baseline, 6 months and 12 months from eplerenone administration
次要结局
- Quality of Life(Baseline, 6 months, 12 months from eplerenone administration)
- 6 Minute Walk(Baseline, 6 months, 12 months from eplerenone administration)
研究者
Ari Cedars
Assistant Professor of Medicine
Washington University School of Medicine