NCT04594746

Brief Summary

The investigators will seek to determine the safety and efficacy of high-dose amiodarone (2000mg), given as a single uniform oral dose, for the treatment of acute atrial fibrillation in both a hospital inpatient and ambulatory outpatient setting. The investigators will conduct a placebo-controlled randomized trial, with outcome ascertainment at 48h.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Feb 2022

Typical duration for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 3, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
Last Updated

February 5, 2026

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

October 13, 2020

Last Update Submit

February 2, 2026

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationAmiodarone

Outcome Measures

Primary Outcomes (1)

  • Time to Successful Reversion to Sinus Rhythm

    Time to successful reversion to sinus rhythm (continuous variable), as documented by continuous cardiac monitoring

    48 hours of intervention administration

Secondary Outcomes (2)

  • Conversion Rate to Sinus Rhythm

    48 hours of intervention administration

  • Early Recurrence of Atrial Fibrillation After Initial Reversion to Sinus Rhythm

    48 hours of intervention administration

Study Arms (2)

Oral Amiodarone

EXPERIMENTAL

Amiodarone hydrochloride 2000 mg

Drug: Amiodarone Hydrochloride

Placebo

PLACEBO COMPARATOR

Oral placebo

Drug: Placebo

Interventions

Amiodarone HydrochlorideDRUG

Amiodarone hydrochloride 2000 mg PO to be given as a 10-capsule dose pack and ingested in a single sitting with food

Also known as: Cordarone, Nexterone
Oral Amiodarone
PlaceboDRUG

Oral placebo to be given as a 10-capsule dose pack and ingested in a single sitting with food

Also known as: Sugar Pill
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute persistent or paroxysmal atrial fibrillation or atrial flutter with duration \< 14 days (continuous with no spontaneous conversions), confirmed by ECG or cardiac telemetry
  • History of symptoms associated with atrial fibrillation
  • Appropriate anticoagulation (warfarin with an international normalized ratio (INR) \> 2.0 or direct oral anticoagulant)

You may not qualify if:

  • Received \> 10 g of amiodarone in the prior 6 months, or other Class III anti-arrhythmic agents in the prior 3 months
  • previous severe adverse event following a cardioversion for atrial fibrillation
  • Hypothyroid and not on thyroid replacement therapy
  • Recent myocardial infarction (within 2 weeks)
  • Acute pulmonary oedema requiring hospital admission or New York Heart Association (NYHA) class IV heart failure
  • Severe left ventricular dysfunction or left ventricular ejection fraction \< 36%, as determined by cardiac imaging
  • Sick sinus syndrome, high grade atrioventricular block, ventricular rate \< 50 beats per minute in the absence of a mechanical pacemaker
  • Severe renal or hepatic disease
  • Known congenital long QT syndrome
  • Hypotension with systolic blood pressure \< 90 mmHg
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

AmiodaroneSugars

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCarbohydrates

Study Officials

  • Satish R Raj, MD MSCI

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Drug and placebo will be encapsulated and blinded by the investigational pharmacy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

February 3, 2022

Primary Completion

January 20, 2026

Study Completion

January 20, 2026

Last Updated

February 5, 2026

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)