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

Primary Purpose

Heart Block, Aortic Stenosis, Bundle-Branch Block

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Methylprednisolone
Placebo
Sponsored by
Hospital General Universitario de Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Block focused on measuring Transcatheter Aortic Valve Replacement, Glucocorticoids, Inflammation, Conduction disturbances, Heart block

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • General University Hospital of AlicanteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group (Glucocorticoid treatment)

Control group

Arm Description

Saline solution (0.9%)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

All-cause mortality
Incidence of strokes (ischemic, hemorrhagic, and/or other unspecified types)
Incidence of bleeding events requiring transfusion or life-threatening bleeding (BARC 3 or 5)
Incidence of major vascular complications
Length of hospital stay
Rate of adverse events related to the use of glucocorticoids
Number of episodes of hyperglycemia, hypertensive crisis, acute decompensated heart failure and local and systemic infections
Pacemaker dependency in patients who have undergone pacemaker implantation
Percentage of stimulation

Full Information

First Posted
September 26, 2023
Last Updated
October 3, 2023
Sponsor
Hospital General Universitario de Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT06076824
Brief Title
Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).
Acronym
GLUCO-TAVR
Official Title
Glucocorticoid Treatment in Patients Undergoing TAVR to Reduce the Incidence of Atrioventricular Block and Pacemaker Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario de Alicante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Aortic stenosis is the most common valvular heart disease in Europe, and its prevalence is expected to increase in the coming years. The definitive treatment is aortic valve replacement through surgery or transcatheter aortic valve implantation (TAVR). TAVR emerged as an alternative to surgery for high-surgical-risk patients, but it has also proven effective in intermediate or low surgical-risk cases, leading to an expected rise in procedures in the near future. The most frequent complication is atrioventricular block (AVB) and permanent pacemaker implantation (PPM), which has been associated with increased morbidity, hospital stay, and healthcare costs. However, it has been suggested that post-TAVR AVB may be a transient process due to the inflammatory response triggered by the procedure. Treating this inflammation could reduce the risk of AVB after TAVR, potentially benefiting both the economy and patient outcomes. The investigators propose a phase IV, single-center, randomized, controlled trial with an unmasked evaluator to evaluate the effect of glucocorticoids on the prevention of conduction abnormalities and PPM in TAVR patients. 100 patients will be recruited (50 in the control group and 50 in the intervention group) undergoing TAVR at the General University Hospital Dr. Balmis in Alicante, excluding those with prior PPM, chronic corticosteroid treatment, or any contraindications to these drugs. 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 inflammatory response and the occurrence of conduction abnormalities will be assessed through blood tests, electrocardiograms, and echocardiography. Data will be processed using IBM-SPSS version 25.0 statistical software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Block, Aortic Stenosis, Bundle-Branch Block
Keywords
Transcatheter Aortic Valve Replacement, Glucocorticoids, Inflammation, Conduction disturbances, Heart block

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Phase IV, single-center, randomized, controlled, and open label clinical trial (with blinded outcomes assessor).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (Glucocorticoid treatment)
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Saline solution (0.9%)
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
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 Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline solution
Intervention Description
Saline solution
Primary Outcome Measure Information:
Title
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).
Time Frame
One week, 30 days, and 1 year after admission
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
One week, 30 days, and 1 year after admission
Title
Incidence of strokes (ischemic, hemorrhagic, and/or other unspecified types)
Time Frame
One week, 30 days, and 1 year after admission
Title
Incidence of bleeding events requiring transfusion or life-threatening bleeding (BARC 3 or 5)
Time Frame
One week after admission
Title
Incidence of major vascular complications
Time Frame
One week and 30 days after admission
Title
Length of hospital stay
Time Frame
One week after admission
Title
Rate of adverse events related to the use of glucocorticoids
Description
Number of episodes of hyperglycemia, hypertensive crisis, acute decompensated heart failure and local and systemic infections
Time Frame
One week and 30 days after admission
Title
Pacemaker dependency in patients who have undergone pacemaker implantation
Description
Percentage of stimulation
Time Frame
At 30 days and one year after admission

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Miguel Ruiz Nodar
Phone
606998408
Email
ruiz_jmi@gva.es
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Fuertes Kenneally
Email
laurafk@hotmail.com
Facility Information:
Facility Name
General University Hospital of Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Miguel Ruiz Nodar
First Name & Middle Initial & Last Name & Degree
Laura Fuertes Kenneally
Email
laurafk@hotmail.com

12. IPD Sharing Statement

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

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