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

NCT ID: NCT03201185

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-10
• Study Completion Date: 2023-08-31

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).

Conditions

Transcatheter Aortic Valve Replacemen; Angiotensin-Converting Enzyme Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ramipril

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

Group Type: EXPERIMENTAL

Ramipril

Intervention Type: DRUG

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).

No intervention

Conventional treatment after transcatheter aortic valve implantation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ramipril

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).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role: lead

Responsible Party

Carlos Baladron, PhD

Research Coordinator, Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Countries

Spain

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Other Identifiers

HCUValladolid

Identifier Type: -

Identifier Source: org_study_id