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

Phase 4

• Conditions: Transcatheter Aortic Valve Replacemen; Angiotensin-Converting Enzyme Inhibitors
• Interventions: Drug: Ramipril

• Registration Number: NCT03201185
• Lead Sponsor: Hospital Clínico Universitario de Valladolid

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Start: 2018-02-10
• Primary Completion: 2021-08-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants that had the occurrence of cardiovascular events (cardiac death, heart failure admission and stroke).	Up to 36 months	Number of participants that had first occurrence of cardiovascular events, which is defined as either cardiac death or heart failure hospitalization or stroke

Secondary Outcome Measures

Name	Time	Method
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	Up to 12 months	Myocardial fibrosis will be measured in grams
Change from baseline to month 12 for the six minutes walk test in order to assess functional capacity.	Up to 12 months	Assessed by six minutes walk test at 12 months
Number of patients dead due to cardiac causes.	Up to 12 and 36 months	Number of patients dead due to cardiac causes at 12 and 36 months.
Number of patients with stroke (Defined as compatible symptoms or confirmed by imaging technique: MRI or CT) during the trial.	Up to 12 and 36 months	Number of patients with stroke during the trial at 12 and 36 months.
Number of patients admitted due to heart failure.	Up to 12 and 36 months	Number of patients admitted due to heart failure at 12 and 36 months.
Number of patients - All-cause mortality	Up to 12 and 36 months	All-cause mortality measures how many patients had this event at 12 and 36 months.

Trial Locations

Locations (1)

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain