drugset / Trial / NCT04696185
Dapagliflozin After Transcatheter Aortic Valve Implantation
Phase 4
Completed
1257 enrolled
Spanish Society of Cardiology
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
Pragmatic, controlled, prospective, randomized, open-label (open-label), evaluator-blind clinical trial (PROBE design) that will analyze the benefits of dapagliflozin treatment in patients with severe aortic stenosis discharged after implantation of an aortic valve prosthesis transcatheter (TAVI).
Timeline
- Start
- 2021-01-27
- Primary completion
- 2024-12-29
- Completion
- 2024-12-30
Publications
- Results Amat-Santos IJ, Sanchez-Luna JP, Abu-Assi E, Melendo-Viu M, Cruz-Gonzalez I, Nombela-Franco L, Munoz-Garci AJ, Blas SG, de la Torre Hernandez JM, Romaguera R, Sanchez-Recalde A, Diez-Gil JL, Lopez-Otero D, Gheorge L, Ibanez B, Iniguez-Romo A, Raposeiras-Roubin S; Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Investigators. Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. Eur J Heart Fail. 2022 Mar;24(3):581-588. doi: 10.1002/ejhf.2370. Epub 2021 Nov 9.
- Bonanad-Lozano C, Garcia Blas S, Amat-Santos I, Gonzalez-Manzanares R, Sanchis J, Lopez Otero D, Nombela Franco L, Gheorge L, Sanz-Sanchez J, Baladron Zorita C, Iniguez Romo A, Munoz Garcia AJ, Vilalta V, Ojeda S, Veiga Fernandez G, Cordoba Soriano JG, Cepas P, Sandin Rollan M, Rios XF, Palma-Carbajal R, Martin Reyes R, Romaguera R, Avanzas P, Franco-Pelaez JA, Martin Moreiras J, Gonzalez Juanatey JR, Tirado G, Calle G, Diez JL, Santos-Martinez S, Dominguez Erquicia P, Garcia EM, Fernandez-Nofrerias E, Lopez Pais J, Gonzalo N, Barri AG, Asmarats L, Lopez Perez M, Dominguez Rodriguez LM, Cobo M, Gonzalez Bermudez I, Garcia Alvarez A, Garcia Pavia P, Fuster V, Ibanez B, Raposeiras-Roubin S. Effect of Dapagliflozin on Quality of Life of Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. J Am Coll Cardiol. 2025 Oct 14;86(15):1128-1138. doi: 10.1016/j.jacc.2025.07.051.
- Raposeiras-Roubin S, Amat-Santos IJ, Rossello X, Gonzalez Ferreiro R, Gonzalez Bermudez I, Lopez Otero D, Nombela-Franco L, Gheorghe L, Diez JL, Baladron Zorita C, Baz JA, Munoz Garcia AJ, Vilalta V, Ojeda-Pineda S, de la Torre Hernandez JM, Cordoba Soriano JG, Regueiro A, Bordes Siscar P, Salgado Fernandez J, Garcia Del Blanco B, Martin-Reyes R, Romaguera R, Moris C, Garcia Blas S, Franco-Pelaez JA, Cruz-Gonzalez I, Arzamendi D, Romero Rodriguez N, Diez-Del Hoyo F, Camacho Freire S, Bosa Ojeda F, Astorga Burgo JC, Molina Navarro E, Caballero Borrego J, Ruiz Quevedo V, Sanchez-Recalde A, Peral Disdier V, Alegria-Barrero E, Torres-Llergo J, Feltes G, Fernandez Diaz JA, Cuellas C, Jimenez Britez G, Sanchez-Rubio Lezcano J, Barreiro-Pardal C, Nunez-Gil I, Abu-Assi E, Iniguez-Romo A, Fuster V, Ibanez B; DapaTAVI Investigators. Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2025 Apr 10;392(14):1396-1405. doi: 10.1056/NEJMoa2500366. Epub 2025 Mar 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dapagliflozin | Small molecule | 10 mg | Oral |