Clinical trial NCT03201185: Renin-angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation (RASTAVI)
Official title: Beneficio Del Bloqueo Del Sistema Renina-angiotensina Sobre la evolución clínica y el Remodelado Ventricular Tras la colocación de Una prótesis percutánea aórtica (RASTAVI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Transcatheter Aortic Valve Replacemen
Angiotensin-Converting Enzyme Inhibitors
Keywords: Cardiovascular events
Ventricular remodeling
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of participants that had the occurrence of cardiovascular events (cardiac death, heart failure admission and stroke).
timeFrame: Up to 36 months
Secondary outcomes:
measure: 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
timeFrame: Up to 12 months
measure: Change from baseline to month 12 for the six minutes walk test in order to assess functional capacity.
timeFrame: Up to 12 months
measure: Number of patients dead due to cardiac causes.
timeFrame: Up to 12 and 36 months
measure: Number of patients admitted due to heart failure.
timeFrame: Up to 12 and 36 months
measure: Number of patients with stroke (Defined as compatible symptoms or confirmed by imaging technique: MRI or CT) during the trial.
timeFrame: Up to 12 and 36 months
measure: Number of patients - All-cause mortality
timeFrame: Up to 12 and 36 months
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
References:
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