A Phase III, Randomized, Double-Blind, Placebo Controlled Clinical Trial Evaluating the Benefits and Mechanism Of Action Of Angiotensin-II Receptor Blocker On Cardiovascular Remodeling In Patients With Repaired Coarctation Of Aorta
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Change in Left Ventricular (LV) Fibrosis
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •B/S1 hypertension
- •SBP 100-139 average based on 3 office measurements.
- •Age 18 or Older
- •Previous COA Repair
排除标准
- •Currently on beta blocker (BB) therapy
- •Pregnancy/lactating
- •Hyperkalemia (serum potassium >5.5mmol/L)
- •Severe Aortic or Mitral valve stenosis or regurgitation
- •Epicardial CAD diagnosis
- •Received antihypertensive medications within the past year
研究组 & 干预措施
Amlodipine Group
Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.
干预措施: Amlodipine (Drug)
Placebo Group
Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.
干预措施: Placebo (Drug)
Losartan Group
Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.
干预措施: Losartan (Drug)
结局指标
主要结局
Change in Left Ventricular (LV) Fibrosis
时间窗: Baseline; Week 52
LV fibrosis will be measured via indexed Extracellular Volume (iECV) which will be calculated as extracellular volume fraction (ECV%) x LV End Diastolic Volume Index as evaluated during Cardiac Magnetic Resonance Imaging (CMRI).
次要结局
- Change in Exercise Capacity (peak VO2)(Baseline; Week 52)
研究者
Alexander C. Egbe
Principal Investigator
Mayo Clinic