Renin-angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After… (NCT03201185) | Clinical Trial Compass
UnknownPhase 4
Renin-angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation (RASTAVI)
Spain194 participantsStarted 2018-02-10
Plain-language summary
The investigators aim to demonstrate that ramipril after transcatheter aortic valve implantation has benefits in terms of prognosis, cardiovascular events and ventricular remodeling (MRI).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of participants that had the occurrence of cardiovascular events (cardiac death, heart failure admission and stroke).
Timeframe: Up to 36 months
Trial details
NCT IDNCT03201185
SponsorHospital ClĂnico Universitario de Valladolid