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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-12

Study Completion Date

2024-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Block Aortic Stenosis Bundle-Branch Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group (Glucocorticoid treatment)

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type 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).

Control group

Saline solution (0.9%)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline solution

Interventions

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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).

Intervention Type DRUG

Placebo

Saline solution

Intervention Type OTHER

Other Intervention Names

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Saline solution

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No