Clinical trial NCT04696185: Dapagliflozin After Transcatheter Aortic Valve Implantation
Official title: Dapagliflozin After Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Stenosis
Transcatether Aortic Valve Implantation
Keywords: Aortic Stenosis
TAVI
Dapagliflozin
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
Collaborators: name: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
First posted: 2021-01-06
Enrollment: 1257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Incidence rate of the composite of all-cause mortality or worsening heart failure (HF)
timeFrame: 1 year
Secondary outcomes:
measure: Incidence rate all-cause mortality
timeFrame: 1 year
measure: Incidence rate of Cardiovascular death
timeFrame: 1 year
measure: Incidence rate of Hospitalization for Heart Failure
timeFrame: 1 year
measure: Incidence rate of Urgent Heart Failure visits
timeFrame: 1 year
measure: Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death
timeFrame: 1 year
measure: Total number of Heart Failure hospitalizations and Cardiovascular deaths
timeFrame: 1 year
Other outcomes:
measure: Improvement in NYHA class.
timeFrame: 1 year
measure: Incidence of new Atrial Fibrillation
timeFrame: 1 year
measure: Safety endpoints
timeFrame: 1 year
measure: Rate of treatment switch (crossovers)
timeFrame: 1 year
Locations:
city: Albacete
country: Spain
facility: Hospital Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Centro Médico TEKNON
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital German I Trias
city: Barcelona
country: Spain
facility: Hospital Universitario Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D´Hebron
city: Cadiz
country: Spain
facility: Hospital Puerta Del Mar
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
city: Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Granada
country: Spain
facility: Hospital Virgen de Las Nieves
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Jaen
country: Spain
facility: Hospital Universitario de Jaen
city: León
country: Spain
facility: Hospital Universitario de León
city: Madrid
country: Spain
facility: Clinica La Luz
city: Madrid
country: Spain
facility: Clinica Nuestra Señora de América de Madrid
city: Madrid
country: Spain
facility: Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario de Torrejón
city: Málaga
country: Spain
facility: Hospital Virgen de La Victoria
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: University Hospital Alvaro Cunqueiro, Vigo, Spain
name: EMAD ABU ASSI, PhD, MD
role: STUDY_CHAIR
affiliation: Centro Nacional de Investigaciones Cardiovasculares (CNIC, Madrid, Spain)
name: BORJA IBAÑEZ, PhD, MD
role: STUDY_DIRECTOR
affiliation: University Hospital Alvaro Cunqueiro, Vigo, Spain
name: SERGIO RAPOSEIRAS ROUBIN, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario de Valladolid
name: IGANCIO AMAT SANTOS, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amat-Santos IJ, Sanchez-Luna JP, Abu-Assi E, Melendo-Viu M, Cruz-Gonzalez I, Nombela-Franco L, Munoz-Garci AJ, Blas SG, de la Torre Hernandez JM, Romaguera R, Sanchez-Recalde A, Diez-Gil JL, Lopez-Otero D, Gheorge L, Ibanez B, Iniguez-Romo A, Raposeiras-Roubin S; Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Investigators. Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. Eur J Heart Fail. 2022 Mar;24(3):581-588. doi: 10.1002/ejhf.2370. Epub 2021 Nov 9.