Dapagliflozin After Transcatheter Aortic Valve Implantation

Spanish Society of Cardiology1,257 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,257

Conditions

Aortic Stenosis Transcatether Aortic Valve Implantation

Interventions

Dapagliflozin 10 MGDRUG

Dapagliflozin 10 mg (daily oral dose)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (40)

Outcomes

Primary Outcomes

Incidence rate of the composite of all-cause mortality or worsening heart failure (HF)

All-cause mortality and worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).

Time frame: 1 year

Secondary Outcomes

Incidence rate all-cause mortality

All cause mortality

Time frame: 1 year

Incidence rate of Cardiovascular death

Mortality secondary to cardiovascular cause

Time frame: 1 year

Incidence rate of Hospitalization for Heart Failure

Heart Failure requiring hospital admission

Time frame: 1 year

Incidence rate of Urgent Heart Failure visits

Urgent Heart Failure visit requiring intravenous therapy

Time frame: 1 year

Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death

Composite of Heart Failure hospitalization or Cardiovascular death

Time frame: 1 year

Total number of Heart Failure hospitalizations and Cardiovascular deaths

Total number of (first and recurrent) Heart Failure hospitalizations and Cardiovascular deaths

Time frame: 1 year

Data from ClinicalTrials.gov

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Hospital Juan Canalejo

A Coruña, Spain

Hospital Universitario de Albacete

Albacete, Spain

Hospital General Universitario de Alicante

Alicante, Spain

Hospital Universitario de Cruces

Barakaldo, Spain

Centro Médico TEKNON

Barcelona, Spain

Hospital Clinic

Barcelona, Spain

Hospital de Bellvitge

Barcelona, Spain

Hospital German I Trias

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Hospital Universitario Sant Pau

Barcelona, Spain

Hospital Universitario Vall D´Hebron

Barcelona, Spain

...and 30 more locations