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

NCT03201185 | Unknown Phase 4 DMC

• 1 other identifier: HCUValladolid
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiovascular events; Ventricular remodeling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

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

  Up to 12 months

• Number of patients dead due to cardiac causes.

  Up to 12 and 36 months

• Number of patients admitted due to heart failure.

  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.

  Up to 12 and 36 months

Study Arms (2)

Ramipril

EXPERIMENTAL

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

Drug: Ramipril

No intervention

NO INTERVENTION

Conventional treatment after transcatheter aortic valve implantation

Interventions

Ramipril 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).

Ramipril

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transcatheter aortic valve implantation due to severe aortic stenosis.
• Patients must give written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Related Publications (31)

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MeSH Terms

Conditions

Ventricular Remodeling

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator, Cardiology

Model Details: Open-label

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: February 10, 2018
• Primary Completion: August 13, 2021
• Study Completion: August 1, 2023
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

ES (1)