Dapagliflozin After Transcatheter Aortic Valve Implantation

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Society of Cardiology
• Collaborator: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

Inclusion Criteria:

• SEVERE AORTIC STENOSIS UNDERWENT TAVI

• PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:

1. Left ventricular ejection fraction ≤ 40% or

2. Diabetes mellitus or

3. Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2

Exclusion Criteria:

• Known allergy or intolerance to SGLT2 inhibitors.

• Concomitant therapy with sulfonylurea or SGLT2 inhibitors..

• Systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg.

• An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m2.

• 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).

• Pregnant or breast-feeding patients

• Patients participating in other clinical trials.