Renin-angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation (RASTAVI)

• Status: Active, not recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clínico Universitario de Valladolid; Luis Varela-Falcon
• Collaborator: Hospital Clínico Universitario de Valladolid
• Treatments: Ramipril

Criteria

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