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Efficacy of steroid treatment on heart blocks secondary to heart valve surgery

Phase 3
Recruiting
Conditions
Advanced atrioventricular block following heart valve surgery.
Atrioventricular and left bundle-branch block
Registration Number
IRCT20180430039488N1
Lead Sponsor
Tehran Heart Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
150
Inclusion Criteria

Presence of advanced atrioventricular block following heart valve surgery including valve replacement or repair with or without CABG
Written documented informed consent

Exclusion Criteria

Exclusion of patients having cardiac pacemakers or intracardiac defibrilator-cardiovertor or CRT
Exclusion of subjects having prior advanced AV block with underlying congenital or acquired etiologies or known brady-arrhythmia
Exclusion of patients with acute or recent myocardial infarction or CPR during last week (or survivors of aborted sudden cardiac death)
Exclusion of diabetics with uncontrolled hyperglycemia ( BS>200 in 2 or more measurements out of 4 samples during last 24 hours or HbA1C>9, ketoacidosis or hyperglycemic hyperosmolar state)
Exclusion of patients with active infections
Exclusion of patients with immune deficiency disorders including malignancies and HIV-AIDS,....
Exclusion of patients with prior history of hypersensitivity reactions to steroids
Exclusion of patients with persistent or permanent atrial fibrillation (AF for more than 24 hours except transient or paroxysmal cases)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Frequency or recovery of AV block. Timepoint: 5days. Method of measurement: Duration of AV block in hours and percentage of recovery after 5 days.
Secondary Outcome Measures
NameTimeMethod
Incidence rate of of PPM implantation. Timepoint: One month. Method of measurement: Observation and follow-up.Percentage of patients in each group who ultimately undergone PPM implantation.
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