Dapagliflozin After Transcatheter Aortic Valve Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2024-12-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Aortic Stenosis Transcatether Aortic Valve Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

All events will be adjudicated by the Clinical Events Adjudication Committee (CEAC), without information about the therapy (intervention or control) (blinded endpoint)

Study Groups

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Dapagliflozin

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

Group Type ACTIVE_COMPARATOR

Dapagliflozin 10 MG

Intervention Type DRUG

Dapagliflozin 10 mg (daily oral dose)

Standard care

No SGLT-2 inhibitor therapy with dapagliflozin

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dapagliflozin 10 MG

Dapagliflozin 10 mg (daily oral dose)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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SERGIO RAPOSEIRAS ROUBIN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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EMAD ABU ASSI, PhD, MD

Role: STUDY_CHAIR

University Hospital Alvaro Cunqueiro, Vigo, Spain

BORJA IBAÑEZ, PhD, MD

Role: STUDY_DIRECTOR

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

SERGIO RAPOSEIRAS ROUBIN, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Alvaro Cunqueiro, Vigo, Spain

IGANCIO AMAT SANTOS, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario de Valladolid

Zaragoza, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT

PMID: 34693613 (View on PubMed)

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.

Reference Type DERIVED

PMID: 41062227 (View on PubMed)

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.

Reference Type DERIVED

PMID: 40162639 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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SEC-DAPATAVI-2020

Identifier Type: -

Identifier Source: org_study_id

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Dapagliflozin After Transcatheter Aortic Valve Implantation

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement

Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement

A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis

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Detailed Description

Conditions

Study Design

Study Groups

Dapagliflozin

Dapagliflozin 10 MG

Standard care

Interventions

Dapagliflozin 10 MG

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Spanish Society of Cardiology

Responsible Party

SERGIO RAPOSEIRAS ROUBIN

Principal Investigators

EMAD ABU ASSI, PhD, MD

BORJA IBAÑEZ, PhD, MD

SERGIO RAPOSEIRAS ROUBIN, PhD, MD

IGANCIO AMAT SANTOS, PhD, MD

Locations

Hospital Juan Canalejo

Hospital Universitario de Albacete

Hospital General Universitario de Alicante

Hospital Universitario de Cruces

Centro Médico TEKNON

Hospital Clinic

Hospital de Bellvitge

Hospital German I Trias

Hospital Universitario Sant Pau

Hospital Universitario Vall D´Hebron

Hospital Puerta Del Mar

Hospital Reina Sofia

Hospital San Cecilio

Hospital Virgen de Las Nieves

Hospital Juan Ramón Jiménez

Hospital Universitario de Jaen

Hospital Universitario de León

Clinica La Luz

Clinica Nuestra Señora de América de Madrid

Fundación Jimenez Diaz

Hospital 12 de Octubre

Hospital Clínico San Carlos

Hospital La Princesa

Hospital Puerta de Hierro

Hospital Ramón Y Cajal

Hospital Universitario de Torrejón

Hospital Virgen de La Victoria

Hospital Universitario Central de Asturias

Hospital Son Espases

Hospital Universitario de Navarra

Hospital Universitario de Salamanca

Hospital Universitario de Canarias

Hospital Marqués de Valdecilla

Hospital Clínico de Santiago

Hospital Virgen Del Rocio

Hospital Clínico de Valencia

Hospital La Fe

Hospital Clinico Universitario de Valladolid

Hospital Álvaro Cunqueiro

Hospital Miguel Servet

Countries

References

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

Document Type: Informed Consent Form

Related Links

Other Identifiers