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

October 3, 2023 updated by: Juan Miguel Ruiz Nodar, Hospital General Universitario de Alicante

Glucocorticoid Treatment in Patients Undergoing TAVR to Reduce the Incidence of Atrioventricular Block and Pacemaker Implantation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan Miguel Ruiz Nodar
  • Phone Number: 606998408
  • Email: ruiz_jmi@gva.es

Study Contact Backup

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Recruiting
        • General University Hospital of Alicante
        • Contact:
        • Contact:
          • Juan Miguel Ruiz Nodar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (Glucocorticoid treatment)
Drug: Methylprednisolone
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).
Placebo Comparator: Control group
Saline solution (0.9%)
Other: Placebo
Saline solution
Other Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One week, 30 days, and 1 year after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: One week, 30 days, and 1 year after admission
One week, 30 days, and 1 year after admission
Incidence of strokes (ischemic, hemorrhagic, and/or other unspecified types)
Time Frame: One week, 30 days, and 1 year after admission
One week, 30 days, and 1 year after admission
Incidence of bleeding events requiring transfusion or life-threatening bleeding (BARC 3 or 5)
Time Frame: One week after admission
One week after admission
Incidence of major vascular complications
Time Frame: One week and 30 days after admission
One week and 30 days after admission
Length of hospital stay
Time Frame: One week after admission
One week after admission
Rate of adverse events related to the use of glucocorticoids
Time Frame: One week and 30 days after admission
Number of episodes of hyperglycemia, hypertensive crisis, acute decompensated heart failure and local and systemic infections
One week and 30 days after admission
Pacemaker dependency in patients who have undergone pacemaker implantation
Time Frame: At 30 days and one year after admission
Percentage of stimulation
At 30 days and one year after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario de Alicante

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-116

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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