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

NCT06076824 | Unknown Phase 4 DMC

• 1 other identifier: 2022-116
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Block; Aortic Stenosis; Bundle-Branch Block

Keywords

Transcatheter Aortic Valve Replacement; Glucocorticoids; Inflammation; Conduction disturbances; Heart block

Outcome Measures

Primary Outcomes (1)

• Number of patients that requiere pacemaker implantation and/or who develop new conduction abnormalities (AV block, bundle branch block, and/or non-specific intraventricular conduction disorder).

  One week, 30 days, and 1 year after admission

Secondary Outcomes (7)

• All-cause mortality

  One week, 30 days, and 1 year after admission

• Incidence of strokes (ischemic, hemorrhagic, and/or other unspecified types)

  One week, 30 days, and 1 year after admission

• Incidence of bleeding events requiring transfusion or life-threatening bleeding (BARC 3 or 5)

  One week after admission

• Incidence of major vascular complications

  One week and 30 days after admission

• Length of hospital stay

  One week after admission

Study Arms (2)

Intervention group (Glucocorticoid treatment)

EXPERIMENTAL

Drug: Methylprednisolone

Control group

PLACEBO COMPARATOR

Saline solution (0.9%)

Other: Placebo

Interventions

Methylprednisolone DRUG

The intervention group will recieve 7 mg/kg/day (or a maximum of 500 mg/day) of intravenous Methylprednisolone an hour before TAVR followed by 15 mg / 12h of Prednisone during 5 days after the intervention (starting 24h after the administration of Methylprednisolone).

Intervention group (Glucocorticoid treatment)

Placebo OTHER

Saline solution

Also known as: Saline solution

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for TAVR implantation according to current European Society of Cardiology guidelines: patients with severe symptomatic aortic stenosis that are \> 75 years old or have a high surgical risk.

You may not qualify if:

• Patients with a prior pacemaker.
• Patients with contraindications for the use of glucocorticoids including immunosuppression, active or latent infection, documented hypersensitivity or allergy, insulin-dependent diabetes mellitus, glaucoma (both closed-angle and open-angle), recent intestinal perforation, or acute heart failure.
• Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed).
• Access for TAVR implantation other than femoral (for example, transapical).
• Patients on medication that may interact with glucocorticoids.

Sponsors & Collaborators

• Hospital General Universitario de Alicante: lead

Study Sites (1)

General University Hospital of Alicante

Alicante, 03010, Spain

RECRUITING

MeSH Terms

Conditions

Heart Block; Aortic Valve Stenosis; Bundle-Branch Block; Inflammation

Interventions

Methylprednisolone; Saline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Juan Miguel Ruiz Nodar

CONTACT

606998408; ruiz_jmi@gva.es

Laura Fuertes Kenneally

CONTACT

laurafk@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department of Interventional Cardiology and Principal Investigator

Model Details: Phase IV, single-center, randomized, controlled, and open label clinical trial (with blinded outcomes assessor).

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 11, 2023
• Study Start: August 12, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

ES (1)