Aortic Stenosis, Transcatether Aortic Valve Implantation
Conditions
Keywords
Aortic Stenosis, TAVI, Dapagliflozin
Brief 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).
Detailed 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 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.
Interventions
DRUGDapagliflozin 10 MG
Dapagliflozin 10 mg (daily oral dose)
Sponsors
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Spanish Society of Cardiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of the composite of all-cause mortality or worsening heart failure (HF) | 1 year | All-cause mortality and worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of Cardiovascular death | 1 year | Mortality secondary to cardiovascular cause |
| Incidence rate of Hospitalization for Heart Failure | 1 year | Heart Failure requiring hospital admission |
| Incidence rate of Urgent Heart Failure visits | 1 year | Urgent Heart Failure visit requiring intravenous therapy |
| Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death | 1 year | Composite of Heart Failure hospitalization or Cardiovascular death |
| Total number of Heart Failure hospitalizations and Cardiovascular deaths | 1 year | Total number of (first and recurrent) Heart Failure hospitalizations and Cardiovascular deaths |
| Incidence rate all-cause mortality | 1 year | All cause mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoints | 1 year | 1. Symptomatic hypotension. Symptomatic hypotension includes postural dizziness with systolic blood pressure \< 100 mmHg, and orthostatic hypotension (defined as a decrease of \>20 mmHg in systolic blood pressure or \>10 mmHg in diastolic blood pressure from a supine to a standing position). 2. Major hypoglycemia. Major hypoglucemia is defined as an event where all the following criteria were confirmed by the investigator: (1) the patient experienced symptoms of severe impairment in consciousness or behaviour; (2) the patient needed external assistance; (3) intervention was needed to treat the hypoglycaemia; and (4) there was prompt recovery of acute symptoms following the intervention. 3. Ketoacidosis. 4. Genital or Urinary Infections 5. Amputation 6. Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) |
| Rate of treatment switch (crossovers) | 1 year | Percentage of patients in the dapagliflozin arm who stop this treatment and percentage of patients in standard care arm who start dapagliflozin therapy |
| Incidence of new Atrial Fibrillation | 1 year | Diagnosis of new Atrial Fibrillation in patients without history of atrial fibrillation at baseline |
| Improvement in NYHA class. | 1 year | Functional class according to New York Heart Association classification |
Countries
Spain
Outcome results
None listed