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

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).

Timeline

Start

2018-02-10

Primary completion

2021-08-13

Completion

2023-08

Outcome

Missed primary endpoint

paper The primary end point occurred in 10.6% in the ramipril group versus 12% in the control group (P=0.776) PMID 39291483 ↗

paper did not meet the primary end point PMID 39291483 ↗

Publications

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• Amat-Santos IJ, Lopez-Otero D, Nombela-Franco L, Peral-Disdier V, Gutierrez-Ibanes E, Jimenez-Diaz V, Munoz-Garcia A, Del Valle R, Regueiro A, Ibanez B, Romaguera R, Cuellas Ramon C, Garcia B, Sanchez PL, Gomez-Herrero J, Gonzalez-Juanatey JR, Tirado-Conte G, Fernandez-Aviles F, Raposeiras-Roubin S, Revilla-Orodea A, Lopez-Diaz J, Gomez I, Carrasco-Moraleja M, San Roman JA. Ramipril After Transcatheter Aortic Valve Implantation in Patients Without Reduced Ejection Fraction: The RASTAVI Randomized Clinical Trial. J Am Heart Assoc. 2024 Oct;13(19):e035460. doi: 10.1161/JAHA.124.035460. Epub 2024 Sep 18.
• Amat-Santos IJ, Santos-Martinez S, Lopez-Otero D, Nombela-Franco L, Gutierrez-Ibanes E, Del Valle R, Munoz-Garcia E, Jimenez-Diaz VA, Regueiro A, Gonzalez-Ferreiro R, Benito T, Sanmartin-Pena XC, Catala P, Rodriguez-Gabella T, Delgado-Arana JR, Carrasco-Moraleja M, Ibanez B, San Roman JA. Ramipril in High-Risk Patients With COVID-19. J Am Coll Cardiol. 2020 Jul 21;76(3):268-276. doi: 10.1016/j.jacc.2020.05.040. Epub 2020 May 26.
• Rodriguez-Gabella T, Catala P, Munoz-Garcia AJ, Nombela-Franco L, Del Valle R, Gutierrez 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, Jimenez-Britez G, Zaderenko N, Alfonso F, Gomez I, Carrasco-Moraleja M, Rodes-Cabau J, San Roman Calvar JA, Amat-Santos IJ. Renin-Angiotensin System Inhibition Following Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2019 Aug 6;74(5):631-641. doi: 10.1016/j.jacc.2019.05.055.
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Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramipril	Small molecule	10 mg	—

Indications

No indication recorded.