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

Evaluation of the efficacy of high dose corticosteroid regimen for treatment of postoperative high degree Atrioventricular block after valvular cardiac surgery ; A single blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180430039488N1
Enrollment
150
Registered
2019-03-28
Start date
2019-03-25
Completion date
Unknown
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced atrioventricular block following heart valve surgery. Atrioventricular and left bundle-branch block

Interventions

Intervention 1: Intervention group: Administration of intravenous dexamethasone with dose of 0.4 mg per kg (maximum dose of 35 mg per day) in divided schedule for 3 consecutive days. All patients incl

Sponsors

Tehran Heart Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

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 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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad masoud kabir

Tehran University of Medical Sciences

Fmasoudkabir@sina.tums.ac.ir+98 21 8802 9600

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026