INHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Hypertrophy of left ventricle
研究概览
简要总结
Objective The objective of the study is to assess the structural and functional cardiac effects of treatment with losartan in patients with hypertrophic cardiomyopathy (HCM).
Design The study is a randomized, placebo-controlled, double-blinded trial. The follow-up period is 12 months. 130 patients with HCM will be included in predefined subgroups. Genotype positive relatives with borderline hypertrophy (> 13 mm) will also be included. Data on individuals with borderline hypertrophy will be analysed separately from the rest of the cohort.
Primary outcome Ventricular hypertrophy assessed as left ventricular mass and maximal wall thickness.
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)
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
- •Hypertrophic cardiomyopathy
- •> 18 years
- •Sinus rhythm
排除标准
- •EF < 50 %
- •Treatment with RAS-inhibitor
- •Contraindications to losartan
研究组 & 干预措施
Losartan
干预措施: Losartan (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Hypertrophy of left ventricle
时间窗: 12 months
Left ventricular mass. Maximal wall thickness.
次要结局
未报告次要终点
研究者
Henning Bundgaard
Consultant, dr. med.
Rigshospitalet, Denmark