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The investigators aim to demonstrate that ramipril after transcatheter aortic valve implantation has benefits in terms of prognosis, cardiovascular events and ventricular remodeling (MRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramipril | Experimental | After transcatheter aortic valve implantation, patients will receive ramipril before discharge plus conventional treatment (in patients without ACEI). |
|
| No intervention | No Intervention | Conventional treatment after transcatheter aortic valve implantation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramipril | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that had the occurrence of cardiovascular events (cardiac death, heart failure admission and stroke). | 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 |
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario de Valladolid | Valladolid | 47005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8459080 | Background | Lindroos M, Kupari M, Heikkila J, Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. 1993 Apr;21(5):1220-5. doi: 10.1016/0735-1097(93)90249-z. | |
| 20961243 | Background | Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. |
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Open-label
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Assessed by six minutes walk test at 12 months |
| Up to 12 months |
| Number of patients dead due to cardiac causes. | 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. | 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. | 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 | All-cause mortality measures how many patients had this event at 12 and 36 months. | Up to 12 and 36 months |
| 24678937 | Background | Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29. |
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| 28304219 | Background | Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17. |
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| 10639539 | Background | Heart Outcomes Prevention Evaluation Study Investigators; Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi: 10.1056/NEJM200001203420301. |
| 39291483 | Derived | 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. |
| 32470515 | Derived | 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. |
| 31370954 | Derived | 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. |
| 29440218 | Derived | Amat-Santos IJ, Catala P, Diez Del Hoyo F, Fernandez-Diaz JA, Alonso-Briales JH, Del Trigo M, Regueiro A, Juan-Salvadores P, Serra V, Gutierrez-Ibanes E, Munoz-Garcia AJ, Nombela-Franco L, Sabate M, Jimenez-Diaz VA, Garcia Del Blanco B, Lopez J, Varela-Falcon LH, Sevilla T, Arnold R, Revilla A, San Roman JA. 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. BMJ Open. 2018 Feb 13;8(2):e020255. doi: 10.1136/bmjopen-2017-020255. |
| ID | Term |
|---|---|
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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