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Dapagliflozin After Transcatheter Aortic Valve Implantation

NCT04696185 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1257

Last updated 2025-01-10

No results posted yet for this study

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

Interventions

DRUG

Dapagliflozin 10 MG

Dapagliflozin 10 mg (daily oral dose)

Sponsors & Collaborators

  • Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

    collaborator OTHER

  • Spanish Society of Cardiology

    lead OTHER

Principal Investigators

  • EMAD ABU ASSI, PhD, MD · University Hospital Alvaro Cunqueiro, Vigo, Spain

  • BORJA IBAÑEZ, PhD, MD · Centro Nacional de Investigaciones Cardiovasculares (CNIC, Madrid, Spain)

  • SERGIO RAPOSEIRAS ROUBIN, PhD, MD · University Hospital Alvaro Cunqueiro, Vigo, Spain

  • IGANCIO AMAT SANTOS, PhD, MD · Hospital Clínico Universitario de Valladolid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2024-12-29
Completion
2024-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04696185 on ClinicalTrials.gov