Treatment of Postoperative Atrial Fibrillation - Comparison of Amiodarone and Placebo.

NCT02715687 | Unknown Phase 3

• 1 other identifier: AF Treatment
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-operative atrial fibrillation (POAF) is the most common complication encountered after cardiac surgery; reports show POAF to occur in \~ 35% of patients after CABG. Prophylactic use amiodarone was found to be effective, however, due to serious extracardiac adverse effects therapy is probably appropriate just for patients at high risk for POAF. the common practice for management of POAF is treatment with intravenous Amiodarone until return to sinus rhythm, following which the drug is given orally. Our protocol involves continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of 200mg per day. This protocol is a common practice in many cardiac surgical departments worldwide, nevertheless, it is not evidence-based protocol and it was never examined as such. This study is a randomized placebo controlled trial, to evaluate the requirement for post-discharge treatment with oral Amiodarone.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Postoperative atrial fibrillation

  Post-discharge monitoring with a continous loop-recorder type of ECG monitoring device named "CardioR" will be provided for all participants. The device will continuously record and transmit ECG monitoring to a dedicated monitoring company. All arrhythmias will be recorded and reported.

  30 days after discharge

Secondary Outcomes (1)

• Post-discharge return to admission

  30 days after discharge

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Will receive 30 days treatment with oral placebo of 200mg

Drug: Placebo

Interventional

ACTIVE COMPARATOR

Will receive 30 days treatment with oral Amiodarone of 200mg

Drug: Amiodarone

Interventions

Amiodarone DRUG

Will receive 30 days treatment with oral amniodarone of 200mg

Also known as: amiodacore

Interventional

Placebo DRUG

Will receive 30 days treatment with oral placebo of 200mg

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All post-cardiac surgery patients who developed a hemodynamically stable postoperative atrial fibrillation and returned to sinus rhythm with intravenous amiodarone tretament.

You may not qualify if:

• Post-cardiac surgery patients who developed a non- hemodynamically stable postoperative atrial fibrillation.
• Patients with chronic and/or paroxysmal atrial fibrillation and/or known other cardiac arrhythmia or conduction disturbance.
• Patients with pacemakers.
• Patients with lactose intolerance

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 22, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 22, 2016

Record last verified: 2016-03