Renin-angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation (RASTAVI) (RASTAVI)
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|ClinicalTrials.gov Identifier: NCT03201185|
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Transcatheter Aortic Valve Replacemen Angiotensin-Converting Enzyme Inhibitors||Drug: Ramipril||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||336 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open-label|
|Masking:||Single (Outcomes Assessor)|
|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)|
|Actual Study Start Date :||February 10, 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2023|
After transcatheter aortic valve implantation, patients will receive ramipril before discharge plus conventional treatment (in patients without ACEI).
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
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201185
|Hospital Clínico Universitario de Valladolid||Recruiting|
|Valladolid, Spain, 47005|
|Contact: Luis Varela-Falcón, Dr 983420000 ext 86571 firstname.lastname@example.org|