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

September 23, 2021 updated by: Carlos Baladron, PhD, Hospital Clínico Universitario de Valladolid

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47005
        • Hospital Clínico Universitario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

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).
Time Frame: 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
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
Time Frame: Up to 12 months
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.
Time Frame: Up to 12 months
Assessed by six minutes walk test at 12 months
Up to 12 months
Number of patients dead due to cardiac causes.
Time Frame: Up to 12 and 36 months
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.
Time Frame: Up to 12 and 36 months
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.
Time Frame: Up to 12 and 36 months
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
Time Frame: Up to 12 and 36 months
All-cause mortality measures how many patients had this event at 12 and 36 months.
Up to 12 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clínico Universitario de Valladolid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2018

Primary Completion (Actual)

August 13, 2021

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCUValladolid

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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