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NCT06076824: GLUCO-TAVR

Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).

Status unknown Phase 4 Last updated 11 October 2023
What this trial tests

Phase 4 trial testing Methylprednisolone in Heart Block in 100 participants. Status unknown.

Timeline
12 August 2023
Primary endpoint
1 September 2024
1 September 2024

Quick facts

Lead sponsorHospital General Universitario de Alicante
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment100
Start date12 August 2023
Primary completion1 September 2024
Estimated completion1 September 2024
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital General Universitario de Alicante

Who can join

Eligibility, any sex, with Heart Block or Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in patients undergoing transaortic valve replacement compared to placebo. Participants randomized to the intervention group will receive a single dose of intravenous Methylprednisolone 7 mg/kg/day on the day of the procedure (1 hour before), followed by 15 mg/12 hours of daily Prednisone for 5 days. The primary endpoint is a composite of permanent pacemaker implantation and the occurrence of new conduction abnormalities (any-degree AV block, bundle branch block, or non-specific intraventricular conduction disorder) at discharge, at 30 days and 1 year.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Management of conduction disturbances after TAVI: the last step towards early discharge.
    Muntané-Carol G, Romaguera R, Gómez-Hospital JA, Nuche J, et al · · 2025 · PMID 40607130 · DOI 10.26599/1671-5411.2025.05.004

Verify or expand the search:

Other trials of Methylprednisolone

Trials testing the same drug.

Other recruiting trials for Heart Block

Currently open trials in the same condition.

Other Hospital General Universitario de Alicante trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06076824.

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