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

Conditions

Angiotensin-Converting Enzyme Inhibitors, Transcatheter Aortic Valve Replacemen

Keywords

Cardiovascular events, Ventricular remodeling

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).

Ignacio J. Amat‐Santos, Diego López‐Otero, Luis Nombela‐Franco, Vicente Peral Disdier, Enrique Gutiérrez et al. (24 authors)

Journal of the American Heart Association2024-09-187 citations

10.1161/jaha.124.035460

Angiotensin-converting enzyme inhibitor for post-transcatheter aortic valve implantation patients: study protocol for a multicenter randomized, open-label blinded endpoint control trial.

Liao YB, Xia C, Cheng Y, Li Q, Wei X, Ou Y, Chen F, Li Y, Liu Q, Xiong T, Zhao Z, Peng Y, Wei J, Feng Y, Chen M.

2021-07-183 citations

10.1186/s13063-021-05411-5

Ramipril in High-Risk Patients With COVID-19.

Amat-Santos IJ, Santos-Martinez S, López-Otero D, Nombela-Franco L, Gutiérrez-Ibanes E, Del Valle R, Muñoz-García E, Jiménez-Diaz VA, Regueiro A, González-Ferreiro R, Benito T, Sanmartin-Pena XC, Catalá P, Rodríguez-Gabella T, Delgado-Arana JR, Carrasco-Moraleja M, Ibañez B, San Román JA.

2020-05-2651 citations

10.1016/j.jacc.2020.05.040

Renin-Angiotensin System Inhibition Following Transcatheter Aortic Valve Replacement.

Rodriguez-Gabella T, Catalá P, Muñoz-García AJ, Nombela-Franco L, Del Valle R, Gutiérrez E, Regueiro A, Jimenez-Diaz VA, Ribeiro HB, Rivero F, Fernandez-Diaz JA, Pibarot P, Alonso-Briales JH, Tirado-Conte G, Moris C, Diez Del Hoyo F, Jiménez-Britez G, Zaderenko N, Alfonso F, Gómez I, Carrasco-Moraleja M, Rodés-Cabau J, San Román Calvar JA, Amat-Santos IJ.

2019-08-0163 citations

10.1016/j.jacc.2019.05.055

Impact of renin-angiotensin system inhibitors on clinical outcomes and ventricular remodelling after transcatheter aortic valve implantation: rationale and design of the RASTAVI randomised multicentre study

Ignacio J. Amat‐Santos, Pablo Catalá, Felipe Díez‐Delhoyo, José Díaz, Juan H. Alonso‐Briales et al. (21 authors)

BMJ Open2018-02-0129 citations

10.1136/bmjopen-2017-020255

Interventions

DRUGRamipril

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Open-label

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants that had the occurrence of cardiovascular events (cardiac death, heart failure admission and stroke).	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

Secondary

Measure	Time frame	Description
Change from baseline to month 12 for the six minutes walk test in order to assess functional capacity.	Up to 12 months	Assessed by six minutes walk test at 12 months
Number of patients dead due to cardiac causes.	Up to 12 and 36 months	Number of patients dead due to cardiac causes at 12 and 36 months.
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	Myocardial fibrosis will be measured in grams
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	Number of patients with stroke during the trial at 12 and 36 months.
Number of patients - All-cause mortality	Up to 12 and 36 months	All-cause mortality measures how many patients had this event at 12 and 36 months.
Number of patients admitted due to heart failure.	Up to 12 and 36 months	Number of patients admitted due to heart failure at 12 and 36 months.

Countries

Spain

Outcome results

None listed