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

Phase 4UnknownNCT03201185

Hospital Clínico Universitario de Valladolid194 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

194

Conditions

Transcatheter Aortic Valve Replacemen Angiotensin-Converting Enzyme Inhibitors

Interventions

RamiprilDRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Outcomes

Primary Outcomes

Number of participants that had the occurrence of cardiovascular events (cardiac death, heart failure admission and stroke).

Number of participants that had first occurrence of cardiovascular events, which is defined as either cardiac death or heart failure hospitalization or stroke

Time frame: Up to 36 months

Secondary Outcomes

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

Myocardial fibrosis will be measured in grams

Time frame: Up to 12 months

Change from baseline to month 12 for the six minutes walk test in order to assess functional capacity.

Assessed by six minutes walk test at 12 months

Time frame: Up to 12 months

Number of patients dead due to cardiac causes.

Number of patients dead due to cardiac causes at 12 and 36 months.

Time frame: Up to 12 and 36 months

Number of patients admitted due to heart failure.

Number of patients admitted due to heart failure at 12 and 36 months.

Time frame: 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.

Number of patients with stroke during the trial at 12 and 36 months.

Time frame: Up to 12 and 36 months

Number of patients - All-cause mortality

All-cause mortality measures how many patients had this event at 12 and 36 months.

Data from ClinicalTrials.gov

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