Duration of Amiodarone therapy required for new post cardiac surgery atrial fibrillation. - Amiodarone administration period for post cardiac surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002208-14-GB

Enrollment

170

Registered

2005-06-30

Start date

2005-02-21

Completion date

Unknown

Last updated

2013-07-15

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

Conditions

Atrial fibrillation following cardiac surgery.

Interventions

Trade Name: Amiodarone Product Name: Amiodarone Product Code: Amiodarone Pharmaceutical Form: Tablet INN or Proposed INN: Amiodarone Hydrochloride CAS Number: unknown Current Sponsor code: Amiodarone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Aged over 18 years • New paroxysmal atrial fibrillation occurring following cardiac surgery • Able to give informed consent • Geographically stable and able to attend routine follow up appointments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • History of atrial fibrillation prior to surgery • Intolerance to Amiodarone or allergy to iodine • Postoperative atrial fibrillation not responding to intravenous amiodarone or antiarrhythmic therapy within 72 hours on onset. • Recurrence of atrial fibrillation • Women who are pregnant or lactating.

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the required duration of amiodarone therapy when administered for the treatment of post cardiac surgery new paroxysmal atrial fibrillation occurrence.;Secondary Objective: To documentation of any side effects in this group of patients;Primary end point(s): It is anticipated that the study will enable the expansion of knowledge regarding the most appropriate duration of Amiodarone treatment for post cardiac surgery paroxysmal atrial fibrillation. It is hoped that this knowledge will improve the care and treatment outcomes of future patients requiring treatment for paroxysmal atrial fibrillation following cardiac surgery.	—

Measure

Time frame

Main Objective: To explore the required duration of amiodarone therapy when administered for the treatment of post cardiac surgery new paroxysmal atrial fibrillation occurrence.;Secondary Objective: To documentation of any side effects in this group of patients;Primary end point(s): It is anticipated that the study will enable the expansion of knowledge regarding the most appropriate duration of Amiodarone treatment for post cardiac surgery paroxysmal atrial fibrillation. It is hoped that this knowledge will improve the care and treatment outcomes of future patients requiring treatment for paroxysmal atrial fibrillation following cardiac surgery.

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Countries

United Kingdom

Outcome results

None listed

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