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

Aortic Stenosis Clinical Trial

— GLUCO-TAVR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076824
• Other study ID #: 2022-116
• Status: Recruiting
• Phase: Phase 4
• Start date: August 12, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2023
• Source: Hospital General Universitario de Alicante
• Contact: Juan Miguel Ruiz Nodar
• Phone: 606998408
• Email: ruiz_jmi[@]gva.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Bundle-Branch Block
• Heart Block

Intervention

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).

Other:
• Placebo
Saline solution

Locations

Country	Name	City	State
Spain	General University Hospital of Alicante	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario de Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality		One week, 30 days, and 1 year after admission
Secondary	Incidence of strokes (ischemic, hemorrhagic, and/or other unspecified types)		One week, 30 days, and 1 year after admission
Secondary	Incidence of bleeding events requiring transfusion or life-threatening bleeding (BARC 3 or 5)		One week after admission
Secondary	Incidence of major vascular complications		One week and 30 days after admission
Secondary	Length of hospital stay		One week after admission
Secondary	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	One week and 30 days after admission
Secondary	Pacemaker dependency in patients who have undergone pacemaker implantation	Percentage of stimulation	At 30 days and one year after admission