NCT03432663

Time-dependent Amiodarone Treatment in Atrial Fibrillation

Completed Phase 4 Last updated 14 February 2018

What this trial tests

Phase 4 trial testing Intravenous amiodarone(1) in Atrial Fibrillation in 60 participants. Completed in 30 November 2009.

Timeline

1 August 2008

Primary endpoint
30 November 2009

30 November 2009

Quick facts

Lead sponsor	Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 August 2008
Primary completion	30 November 2009
Estimated completion	30 November 2009
Sites	1 location across Mexico

Drugs / interventions tested

• Intravenous amiodarone(1) — full drug profile →
• Intravenous amiodarone(2) — full drug profile →

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized into two groups. The first received intravenous amiodarone infusions continuously for 24 hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours.

The efficacy and safety of administering intravenous infusions of amiodarone for up to 72 hours were investigated and compared to the efficacy and safety of administering a standard 24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was considered as a new strategy to improve rates of conversion to sinus rhythm without altering the safety profile of the drug.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.