Dapagliflozin After Transcatheter Aortic Valve Implantation

NCT04696185 | Completed Phase 4 DMC

• 1 other identifier: SEC-DAPATAVI-2020
• Study Type: interventional
• Target: 1,257
• Locations: 1 country
• Sites: 40

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).

Conditions

Aortic Stenosis; Transcatether Aortic Valve Implantation

Keywords

Aortic Stenosis; TAVI; Dapagliflozin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence rate all-cause mortality

  1 year

• Incidence rate of Cardiovascular death

  1 year

• Incidence rate of Hospitalization for Heart Failure

  1 year

• Incidence rate of Urgent Heart Failure visits

  1 year

• Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death

  1 year

Other Outcomes (4)

• Improvement in NYHA class.

  1 year

• Incidence of new Atrial Fibrillation

  1 year

• Safety endpoints

  1 year

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

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

Drug: Dapagliflozin 10 MG

Standard care

NO INTERVENTION

No SGLT-2 inhibitor therapy with dapagliflozin

Interventions

Dapagliflozin 10 MG DRUG

Dapagliflozin 10 mg (daily oral dose)

Dapagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Society of Cardiology: lead
• Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III: collaborator

Study Sites (40)

Hospital Juan Canalejo

A Coruña, Spain

Location

Hospital Universitario de Albacete

Albacete, Spain

Location

Hospital General Universitario de Alicante

Alicante, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Spain

Location

Centro Médico TEKNON

Barcelona, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital de Bellvitge

Barcelona, Spain

Location

Hospital German I Trias

Barcelona, Spain

Location

Hospital Universitario Sant Pau

Barcelona, Spain

Location

Hospital Universitario Vall D´Hebron

Barcelona, Spain

Location

Hospital Puerta Del Mar

Cadiz, Spain

Location

Hospital Reina Sofia

Córdoba, Spain

Location

Hospital San Cecilio

Granada, Spain

Location

Hospital Virgen de Las Nieves

Granada, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, Spain

Location

Hospital Universitario de Jaen

Jaén, Spain

Location

Hospital Universitario de León

León, Spain

Location

Clinica La Luz

Madrid, Spain

Location

Clinica Nuestra Señora de América de Madrid

Madrid, Spain

Location

Fundación Jimenez Diaz

Madrid, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital La Princesa

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Hospital Ramón Y Cajal

Madrid, Spain

Location

Hospital Universitario de Torrejón

Madrid, Spain

Location

Hospital Virgen de La Victoria

Málaga, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Son Espases

Palma de Mallorca, Spain

Location

Hospital Universitario de Navarra

Pamplona, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

Hospital Marqués de Valdecilla

Santander, Spain

Location

Hospital Clínico de Santiago

Santiago de Compostela, Spain

Location

Hospital Virgen Del Rocio

Seville, Spain

Location

Hospital Clínico de Valencia

Valencia, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

Related Publications (3)

• 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.

  PMID: 34693613 RESULT

• Bonanad-Lozano C, Garcia Blas S, Amat-Santos I, Gonzalez-Manzanares R, Sanchis J, Lopez Otero D, Nombela Franco L, Gheorge L, Sanz-Sanchez J, Baladron Zorita C, Iniguez Romo A, Munoz Garcia AJ, Vilalta V, Ojeda S, Veiga Fernandez G, Cordoba Soriano JG, Cepas P, Sandin Rollan M, Rios XF, Palma-Carbajal R, Martin Reyes R, Romaguera R, Avanzas P, Franco-Pelaez JA, Martin Moreiras J, Gonzalez Juanatey JR, Tirado G, Calle G, Diez JL, Santos-Martinez S, Dominguez Erquicia P, Garcia EM, Fernandez-Nofrerias E, Lopez Pais J, Gonzalo N, Barri AG, Asmarats L, Lopez Perez M, Dominguez Rodriguez LM, Cobo M, Gonzalez Bermudez I, Garcia Alvarez A, Garcia Pavia P, Fuster V, Ibanez B, Raposeiras-Roubin S. Effect of Dapagliflozin on Quality of Life of Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. J Am Coll Cardiol. 2025 Oct 14;86(15):1128-1138. doi: 10.1016/j.jacc.2025.07.051.

  PMID: 41062227 DERIVED

• Raposeiras-Roubin S, Amat-Santos IJ, Rossello X, Gonzalez Ferreiro R, Gonzalez Bermudez I, Lopez Otero D, Nombela-Franco L, Gheorghe L, Diez JL, Baladron Zorita C, Baz JA, Munoz Garcia AJ, Vilalta V, Ojeda-Pineda S, de la Torre Hernandez JM, Cordoba Soriano JG, Regueiro A, Bordes Siscar P, Salgado Fernandez J, Garcia Del Blanco B, Martin-Reyes R, Romaguera R, Moris C, Garcia Blas S, Franco-Pelaez JA, Cruz-Gonzalez I, Arzamendi D, Romero Rodriguez N, Diez-Del Hoyo F, Camacho Freire S, Bosa Ojeda F, Astorga Burgo JC, Molina Navarro E, Caballero Borrego J, Ruiz Quevedo V, Sanchez-Recalde A, Peral Disdier V, Alegria-Barrero E, Torres-Llergo J, Feltes G, Fernandez Diaz JA, Cuellas C, Jimenez Britez G, Sanchez-Rubio Lezcano J, Barreiro-Pardal C, Nunez-Gil I, Abu-Assi E, Iniguez-Romo A, Fuster V, Ibanez B; DapaTAVI Investigators. Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2025 Apr 10;392(14):1396-1405. doi: 10.1056/NEJMoa2500366. Epub 2025 Mar 29.

  PMID: 40162639 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• EMAD ABU ASSI, PhD, MD

  University Hospital Alvaro Cunqueiro, Vigo, Spain

  STUDY CHAIR

• BORJA IBAÑEZ, PhD, MD

  Centro Nacional de Investigaciones Cardiovasculares (CNIC, Madrid, Spain)

  STUDY DIRECTOR

• SERGIO RAPOSEIRAS ROUBIN, PhD, MD

  University Hospital Alvaro Cunqueiro, Vigo, Spain

  PRINCIPAL INVESTIGATOR

• IGANCIO AMAT SANTOS, PhD, MD

  Hospital Clínico Universitario de Valladolid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All events will be adjudicated by the Clinical Events Adjudication Committee (CEAC), without information about the therapy (intervention or control) (blinded endpoint)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 6, 2021
• Study Start: January 27, 2021
• Primary Completion: December 29, 2024
• Study Completion: December 30, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years
• Access Criteria: Email (dapatavi@gmail.com)

Locations

ES (40)