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

Hospital Clínico Universitario de Valladolid

Status and phase: Unknown; Phase 4

Conditions: Angiotensin-Converting Enzyme Inhibitors; Transcatheter Aortic Valve Replacemen

Treatments: Drug: Ramipril

Study type: Interventional

Funder types: Other

Identifiers

NCT03201185

HCUValladolid

Details and patient eligibility

About

The investigators aim to demonstrate that ramipril after transcatheter aortic valve implantation has benefits in terms of prognosis, cardiovascular events and ventricular remodeling (MRI).

Enrollment: 194 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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194 participants in 2 patient groups

Ramipril

Experimental group

Description:

After transcatheter aortic valve implantation, patients will receive ramipril before discharge plus conventional treatment (in patients without ACEI).

Treatment:

Drug: Ramipril

No intervention

No Intervention group

Description:

Conventional treatment after transcatheter aortic valve implantation