Dapagliflozin After Transcatheter Aortic Valve Implantation
Key facts
- Phase
- Phase 4
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Trial details
- Who runs it
- Spanish Society of Cardiology
- Trial code
- NCT04696185
- Record updated
- 10 January 2025
- Original description
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).Read full original descriptionShow less
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).
Inclusion: SEVERE AORTIC STENOSIS UNDERWENT TAVI; PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:; Left ventricular ejection fraction ≤ 40% or; Diabetes mellitus or; Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2.
Exclusion: Concomitant therapy with sulfonylurea or SGLT2 inhibitors; Known allergy or intolerance to SGLT2 inhibitors; Chronic cystitis and/or recurrent urinary tract infections (2 or more in the last year); Poor control of diabetes mellitus that requires SGLT-2 inhibitor prescription on discharge according to treating physician judge; Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year); An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m2; Systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg; Pregnant or breast-feeding patients; Patients participating in other clinical trials.