Dapagliflozin After Transcatheter Aortic Valve Implantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Stenosis
- Transcatether Aortic Valve Implantation
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Dapa-TAVI is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial. Patients being discharged after TAVI who meet all inclusion criteria, and none of the exclusion criteria, will be eligible for the enrollment. Patients will be 1:1 randomized to 1 of these 2 arms: Intervention group: Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg. Control group: no SGLT-2 inhibitor therapy with dapagliflozin. Masking: Single (Outcomes Assessor)Masking Description: All events will be adjudicated by the Clinical Events Adjudication Committee (CEAC), without information about the therapy (intervention or control) (blinded endpoint)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Patients discharged after TAVI, with a history of heart failure (HF) plus depressed left ventricular ejection fraction (LVEF ? 40%) or diabetes mellitus (DM) or glomerular filtration rate (GFR) between 25 and 75 ml/min/1.73 m2, will be randomized (1:1) before hospital discharge to receive treatment ...
Patients discharged after TAVI, with a history of heart failure (HF) plus depressed left ventricular ejection fraction (LVEF ? 40%) or diabetes mellitus (DM) or glomerular filtration rate (GFR) between 25 and 75 ml/min/1.73 m2, will be randomized (1:1) before hospital discharge to receive treatment with dapagliflozin 10 mg/day or no dapagliflozin (no placebo). Only variables available during routine clinical practice will be collected and there will be no additional tests. The incidence of clinical events and adherence to the dapagliflozin arm will be documented at 2 time-points (3 ± 1 months and 12 months) by phone calls and review of medical records.
Tracking Information
- NCT #
- NCT04696185
- Collaborators
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Investigators
- Study Chair: EMAD ABU ASSI, PhD, MD University Hospital Alvaro Cunqueiro, Vigo, Spain Study Director: BORJA IBAÑEZ, PhD, MD Centro Nacional de Investigaciones Cardiovasculares (CNIC, Madrid, Spain) Principal Investigator: SERGIO RAPOSEIRAS ROUBIN, PhD, MD University Hospital Alvaro Cunqueiro, Vigo, Spain Principal Investigator: IGANCIO AMAT SANTOS, PhD, MD Hospital Clínico Universitario de Valladolid
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