Title
Renin-angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation (RASTAVI)
Beneficio Del Bloqueo Del Sistema Renina-angiotensina Sobre la evolución clínica y el Remodelado Ventricular Tras la colocación de Una prótesis percutánea aórtica (RASTAVI)
Phase
Phase 4Lead Sponsor
Hospital Clínico Universitario de ValladolidStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Transcatheter Aortic Valve Replacemen Angiotensin-Converting Enzyme InhibitorsIntervention/Treatment
ramipril ...Study Participants
194The investigators aim to demonstrate that ramipril after transcatheter aortic valve implantation has benefits in terms of prognosis, cardiovascular events and ventricular remodeling (MRI).
Initial dose: 2,5 mg. Up-titrated at one month to 5 mg and 10 mg at three months (following clinical practice recommendations for up-titration). Target dose: 10 mg (or maximum tolerated dose).
After transcatheter aortic valve implantation, patients will receive ramipril before discharge plus conventional treatment (in patients without ACEI).
Conventional treatment after transcatheter aortic valve implantation
Inclusion Criteria: Transcatheter aortic valve implantation due to severe aortic stenosis. Patients must give written informed consent. Exclusion Criteria: 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
