التفاصيل البيبلوغرافية
| العنوان: |
Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. |
| المؤلفون: |
Amat-Santos, Ignacio J., Sánchez-Luna, Juan P., Abu-Assi, Emad, Melendo-Viu, María, Cruz-Gonzalez, Ignacio, Nombela-Franco, Luis, Muñoz-Garcí, Antonio J., Blas, Sergio G., de la TorreHernandez, Jose M., Romaguera, Rafael, Sánchez-Recalde, Ángel, Diez-Gil, José L., Lopez-Otero, Diego, Gheorge, Livia, Ibáñez, Borja, Iñiguez-Romo, Andrés, Raposeiras-Roubín, Sergio |
| المصدر: |
European Journal of Heart Failure. Supplements; Mar2022, Vol. 24 Issue 3, p581-588, 8p |
| مصطلحات موضوعية: |
HEART failure risk factors, DIABETES risk factors, SODIUM-glucose cotransporters, RESEARCH, DRUG efficacy, HEART valve prosthesis implantation, VENTRICULAR ejection fraction, DRUG design, TREATMENT effectiveness, DAPAGLIFLOZIN, LONGITUDINAL method, EVALUATION |
| مستخلص: |
Aims Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospitalization in individuals with diabetes mellitus, reduced left ventricular ejection fraction and chronic kidney disease. However, the effect of SGLT-2 inhibitors on outcomes after TAVI is unknown. The Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) trial is designed to assess the clinical benefit and safety of the SGLT-2 inhibitor dapagliflozin in patients undergoing TAVI. Methods DapaTAVI is an independent pragmatic, controlled, prospective, randomized, open-label blinded endpoint, multicentre trial conducted in Spain, evaluating the effect of dapagliflozin 10 mg/day on the risk of death and worsening HF in patients with severe AS undergoing TAVI. Candidate patients should have prior history of HF admission plus ≥1 of the following criteria: (i) diabetes mellitus, (ii) left ventricular ejection fraction ≤40%, or (iii) estimated glomerular filtration rate between 25 and 75ml/min/1.73m2. A total of 1020 patients will be randomized (1:1) to dapagliflozin vs. no dapagliflozin. Key secondary outcomes include: (i) incidence rate of individual components of the primary outcome; (ii) cardiovascular mortality; (iii) the composite of HF hospitalization or cardiovascular death; and (iv) total number of HF rehospitalizations. Conclusion DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
