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

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

Official Title
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Beneficio Del Bloqueo Del Sistema Renina-angiotensina Sobre la evolución clínica y el Remodelado Ventricular Tras la colocación de Una prótesis percutánea aórtica (RASTAVI)

Conditions
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Transcatheter Aortic Valve Replacemen, Angiotensin-Converting Enzyme Inhibitors

Intervention / Treatment
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* Drug: Ramipril


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramipril<br>After transcatheter aortic valve implantation, patients will receive ramipril before discharge plus conventional treatment (in patients without ACEI). | Drug: Ramipril<br>* 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).<br>|
| No Intervention: No intervention<br>Conventional treatment after transcatheter aortic valve implantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | 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. | 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. | Up to 12 and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular events, Ventricular remodeling