Dapagliflozin After Transcatheter Aortic Valve Implantation
- Conditions
- Aortic StenosisTranscatether Aortic Valve Implantation
- Interventions
- Registration Number
- NCT04696185
- Lead Sponsor
- Spanish Society of Cardiology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1257
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dapagliflozin Dapagliflozin 10 MG Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence rate of Cardiovascular death 1 year Mortality secondary to cardiovascular cause
Incidence rate all-cause mortality 1 year All cause mortality
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
Trial Locations
- Locations (40)
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario de Cruces
🇪🇸Barakaldo, Spain
Hospital Universitario de Albacete
🇪🇸Albacete, Spain
Centro Médico TEKNON
🇪🇸Barcelona, Spain
Hospital Clinic
🇪🇸Barcelona, Spain
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Hospital German I Trias
🇪🇸Barcelona, Spain
Hospital Universitario Sant Pau
🇪🇸Barcelona, Spain
Hospital Puerta Del Mar
🇪🇸Cadiz, Spain
Hospital Virgen de Las Nieves
🇪🇸Granada, Spain
Hospital Reina Sofia
🇪🇸Cordoba, Spain
Hospital Juan Canalejo
🇪🇸Coruña, Spain
Hospital San Cecilio
🇪🇸Granada, Spain
Hospital Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Universitario de Jaen
🇪🇸Jaen, Spain
Hospital Universitario de León
🇪🇸León, Spain
Clinica La Luz
🇪🇸Madrid, Spain
Clinica Nuestra Señora de América de Madrid
🇪🇸Madrid, Spain
Fundación Jimenez Diaz
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Ramón Y Cajal
🇪🇸Madrid, Spain
Hospital Universitario de Torrejón
🇪🇸Madrid, Spain
Hospital Virgen de La Victoria
🇪🇸Málaga, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Son Espases
🇪🇸Palma De Mallorca, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Clínico de Santiago
🇪🇸Santiago De Compostela, Spain
Hospital Virgen Del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario de Canarias
🇪🇸Tenerife, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Universitario Vall D´Hebron
🇪🇸Barcelona, Spain