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Dapagliflozin After Transcatheter Aortic Valve Implantation (DapaTAVI)

Primary Purpose

Aortic Stenosis, Transcatether Aortic Valve Implantation

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dapagliflozin 10 MG
Sponsored by
Spanish Society of Cardiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Aortic Stenosis, TAVI, Dapagliflozin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de AlbaceteRecruiting
  • Hospital General Universitario de AlicanteRecruiting
  • Hospital Universitario de CrucesRecruiting
  • Centro Médico TEKNONRecruiting
  • Hospital ClinicRecruiting
  • Hospital de BellvitgeRecruiting
  • Hospital German I TriasRecruiting
  • Hospital Universitario Sant PauRecruiting
  • Hospital Universitario Vall D´HebronRecruiting
  • Hospital Puerta Del MarRecruiting
  • Hospital Reina SofiaRecruiting
  • Hospital Juan CanalejoRecruiting
  • Hospital San CecilioRecruiting
  • Hospital Virgen de Las NievesRecruiting
  • Hospital Juan Ramón JiménezRecruiting
  • Hospital Universitario de JaenRecruiting
  • Hospital Universitario de LeónRecruiting
  • Clinica La LuzRecruiting
  • Clinica Nuestra Señora de América de MadridRecruiting
  • Fundación Jimenez DiazRecruiting
  • Hospital 12 de OctubreRecruiting
  • Hospital Clínico San CarlosRecruiting
  • Hospital La Princesa
  • Hospital Puerta de HierroRecruiting
  • Hospital Ramón Y CajalRecruiting
  • Hospital Universitario de TorrejónRecruiting
  • Hospital Virgen de La VictoriaRecruiting
  • Hospital Universitario Central de AsturiasRecruiting
  • Hospital Son EspasesRecruiting
  • Hospital Universitario de NavarraRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Marqués de ValdecillaRecruiting
  • Hospital Clínico de SantiagoRecruiting
  • Hospital Virgen Del RocioRecruiting
  • Hospital Universitario de CanariasRecruiting
  • Hospital Clínico de ValenciaRecruiting
  • Hospital La FeRecruiting
  • Hospital Clinico Universitario de ValladolidRecruiting
  • Hospital Álvaro CunqueiroRecruiting
  • Hospital Miguel ServetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Dapagliflozin

Standard care

Arm Description

Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg

No SGLT-2 inhibitor therapy with dapagliflozin

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Incidence rate all-cause mortality
All cause mortality
Incidence rate of Cardiovascular death
Mortality secondary to cardiovascular cause
Incidence rate of worsening heart failure (HF)
Worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).
Incidence rate of atrial fibrillation
Atrial Fibrillation confirmed by ECG

Full Information

First Posted
December 30, 2020
Last Updated
November 17, 2022
Sponsor
Spanish Society of Cardiology
Collaborators
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT04696185
Brief Title
Dapagliflozin After Transcatheter Aortic Valve Implantation
Acronym
DapaTAVI
Official Title
Dapagliflozin After Transcatheter Aortic Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spanish Society of Cardiology
Collaborators
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Transcatether Aortic Valve Implantation
Keywords
Aortic Stenosis, TAVI, Dapagliflozin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
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)
Allocation
Randomized
Enrollment
1020 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Active Comparator
Arm Description
Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
No SGLT-2 inhibitor therapy with dapagliflozin
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10 MG
Intervention Description
Dapagliflozin 10 mg (daily oral dose)
Primary Outcome Measure Information:
Title
Incidence rate of the composite of all-cause mortality or worsening heart failure (HF)
Description
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 Outcome Measure Information:
Title
Incidence rate all-cause mortality
Description
All cause mortality
Time Frame
1 year
Title
Incidence rate of Cardiovascular death
Description
Mortality secondary to cardiovascular cause
Time Frame
1 year
Title
Incidence rate of worsening heart failure (HF)
Description
Worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).
Time Frame
1 year
Title
Incidence rate of atrial fibrillation
Description
Atrial Fibrillation confirmed by ECG
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Improvement in NYHA class.
Description
Functional class according to New York Heart Association classification
Time Frame
1 year
Title
Safety endpoints
Description
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). 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. Ketoacidosis. Genital or Urinary Infections Amputation Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)
Time Frame
1 year
Title
Rate of treatment switch (crossovers)
Description
Percentage of patients in the "dapagliflozin arm" who stop this treatment and percentage of patients in "standard care" arm who start dapagliflozin therapy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SERGIO RAPOSEIRAS ROUBIN, PhD, MD
Phone
034 620170387
Email
raposeiras26@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
IGNACIO AMAT SANTOS, PhD, MD
Phone
034 657923040
Email
ijamat@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMAD ABU ASSI, PhD, MD
Organizational Affiliation
University Hospital Alvaro Cunqueiro, Vigo, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
BORJA IBAÑEZ, PhD, MD
Organizational Affiliation
Centro Nacional de Investigaciones Cardiovasculares (CNIC, Madrid, Spain)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
SERGIO RAPOSEIRAS ROUBIN, PhD, MD
Organizational Affiliation
University Hospital Alvaro Cunqueiro, Vigo, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
IGANCIO AMAT SANTOS, PhD, MD
Organizational Affiliation
Hospital Clínico Universitario de Valladolid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de Albacete
City
Albacete
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Gabriel Córdoba Soriano
Facility Name
Hospital General Universitario de Alicante
City
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PASCUAL BORDES
Facility Name
Hospital Universitario de Cruces
City
Barakaldo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROBERTO BLANCO MATA
Facility Name
Centro Médico TEKNON
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo David Jimenez Britez
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANDER REGUEIRO
Facility Name
Hospital de Bellvitge
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RAFAEL ROMAGUERA
Facility Name
Hospital German I Trias
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Vilalta del Olmo
Facility Name
Hospital Universitario Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dabit Arzamendi Aizpurua
Facility Name
Hospital Universitario Vall D´Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno García
Facility Name
Hospital Puerta Del Mar
City
Cadiz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Livia Gheorge
Facility Name
Hospital Reina Sofia
City
Cordoba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MANUEL PAN
Facility Name
Hospital Juan Canalejo
City
Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Salgado Fernández
Facility Name
Hospital San Cecilio
City
Granada
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUAN CABALLERO
Facility Name
Hospital Virgen de Las Nieves
City
Granada
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Molina Navarro
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Francisco Díaz Fernández
Facility Name
Hospital Universitario de Jaen
City
Jaen
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JAVIER TORRES
Facility Name
Hospital Universitario de León
City
León
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CARLOS CUELLAS
Facility Name
Clinica La Luz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROBERTO MARTIN REYES
Facility Name
Clinica Nuestra Señora de América de Madrid
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GISELA FELTES
Facility Name
Fundación Jimenez Diaz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BORJA IBAÑEZ
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Sarnago Cebada
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Nombela-Franco
Facility Name
Hospital La Princesa
City
Madrid
Country
Spain
Individual Site Status
Suspended
Facility Name
Hospital Puerta de Hierro
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JOSE ANTONIO FERNANDEZ DÍAZ
Facility Name
Hospital Ramón Y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANGEL SANCHEZ RECALDE
Facility Name
Hospital Universitario de Torrejón
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EDUARDO ALEGRIA BARRERO
Facility Name
Hospital Virgen de La Victoria
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO MUÑOZ
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Moris
Facility Name
Hospital Son Espases
City
Palma De Mallorca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Peral Disdier
Facility Name
Hospital Universitario de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeriano Ruiz Quevedo
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IGNACIO CRUZ
Facility Name
Hospital Marqués de Valdecilla
City
Santander
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José María De la Torre
Facility Name
Hospital Clínico de Santiago
City
Santiago De Compostela
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego López Otero
Facility Name
Hospital Virgen Del Rocio
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MANUEL Villa Gil-Ortega
Facility Name
Hospital Universitario de Canarias
City
Tenerife
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRANCISCO BOSA
Facility Name
Hospital Clínico de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SERGIO GARCÍA
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Luis Díez Gil
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IGNACIO AMAT SANTOS
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANDRES IÑIGUEZ ROMO
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUAN SANCHEZ-RUBIO LEZCANO

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data will be available to other researchers after ending the trial, prior to a formal request to the Executive Committee
IPD Sharing Time Frame
5 years
IPD Sharing Access Criteria
Email (dapatavi@gmail.com)
IPD Sharing URL
https://www.dapatavi.com/
Links:
URL
https://www.dapatavi.com/
Description
Web Page of DapaTAVI trial

Learn more about this trial

Dapagliflozin After Transcatheter Aortic Valve Implantation

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