Beneficio Del Bloqueo Del Sistema Renina-angiotensina Sobre la evolución clínica y el Remodelado Ventricular Tras la colocación de Una prótesis percutánea aórtica (RASTAVI)
试验速览
- 阶段
- 4 期
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Number of participants that had the occurrence of cardiovascular events (cardiac death, heart failure admission and stroke).
研究概览
简要总结
The investigators aim to demonstrate that ramipril after transcatheter aortic valve implantation has benefits in terms of prognosis, cardiovascular events and ventricular remodeling (MRI).
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
- Single (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
- •Transcatheter aortic valve implantation due to severe aortic stenosis.
- •Patients must give written informed consent.
排除标准
- •Severe mitral valvulopathy.
- •Reduced left ventricular ejection fraction (LVEF < 40%) with myocardial infarction or dilated cardiomyopathy.
- •Patients on an ACEI or an ARB the last 3 months.
- •History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
- •Non-MR-conditional cardiac devices.
- •Estimated GFR < 30 ml/min. GFR between 30 and 50 ml/min will not receive gadolinium during MRI.
- •Systolic blood pressure < 100 mmHg or diastolic < 40 mmHg.
- •Pregnant women.
- •Participating in other investigational trial at the time of enrollment
研究组 & 干预措施
Ramipril
After transcatheter aortic valve implantation, patients will receive ramipril before discharge plus conventional treatment (in patients without ACEI).
干预措施: Ramipril (Drug)
结局指标
主要结局
Number of participants that had the occurrence of cardiovascular events (cardiac death, heart failure admission and stroke).
时间窗: Up to 36 months
Number of participants that had first occurrence of cardiovascular events, which is defined as either cardiac death or heart failure hospitalization or stroke
次要结局
- Changes in left ventricular remodeling at 12 months assessed by cardiac MRI. Changes in left ventricle ejection fraction, ventricular dimenssions, ventricular mass and myocardial fibrosis will be measured(Up to 12 months)
- Change from baseline to month 12 for the six minutes walk test in order to assess functional capacity.(Up to 12 months)
- Number of patients dead due to cardiac causes.(Up to 12 and 36 months)
- Number of patients with stroke (Defined as compatible symptoms or confirmed by imaging technique: MRI or CT) during the trial.(Up to 12 and 36 months)
- Number of patients admitted due to heart failure.(Up to 12 and 36 months)
- Number of patients - All-cause mortality(Up to 12 and 36 months)
研究者
Carlos Baladron, PhD
Research Coordinator, Cardiology
Hospital Clínico Universitario de Valladolid