Dapagliflozin After Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Dapagliflozin After Transcatheter Aortic Valve Implantation

Conditions
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Aortic Stenosis, Transcatether Aortic Valve Implantation

Intervention / Treatment
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* Drug: Dapagliflozin 10 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dapagliflozin<br>Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg | Drug: Dapagliflozin 10 MG<br>* Dapagliflozin 10 mg (daily oral dose)<br>|
| No Intervention: Standard care<br>No SGLT-2 inhibitor therapy with dapagliflozin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate all-cause mortality | All cause mortality | 1 year | 
| Incidence rate of Cardiovascular death | Mortality secondary to cardiovascular cause | 1 year | 
| Incidence rate of Hospitalization for Heart Failure | Heart Failure requiring hospital admission | 1 year | 
| Incidence rate of Urgent Heart Failure visits | Urgent Heart Failure visit requiring intravenous therapy | 1 year | 
| Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death | Composite of Heart Failure hospitalization or Cardiovascular death | 1 year | 
| Total number of Heart Failure hospitalizations and Cardiovascular deaths | Total number of (first and recurrent) Heart Failure hospitalizations and Cardiovascular deaths | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Stenosis, TAVI, Dapagliflozin