Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Our hypothesis is that episodic amiodarone treatment (i.e. amiodarone treatment 1 month prior until 1 month after cardioversion) is associated with a lower morbidity and a higher quality of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is still effectively suppressed. The latter means that at the end of the study permanent atrial fibrillation is prevented in comparable percentage of patients (70%) in both treatment strategies. However, this will be accomplished at the cost of a higher number of electrical cardioversions (2-3) in the episodic treatment group compared to the continuous treatment group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation

NCT00845780

Persistent Atrial Fibrillation

COMPLETED PHASE4

Prevention of Atrial Fibrillation Following Esophagectomy

NCT00420017

Atrial Fibrillation Esophagectomy

COMPLETED PHASE4

AMIOdarone vs. Catheter Ablation for Prevention of Recurrent Symptomatic Atrial Fibrillation

NCT02341105

Atrial Fibrillation

TERMINATED PHASE4

Prevention of New Onset AF After TAVI (PAF-TAVI Trial)

NCT03991754

Atrial Fibrillation New Onset

UNKNOWN PHASE3

Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation

NCT06742866

Atrial Fibrillation (AF)

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary objective

To determine differences in adverse event rates between patients with persistent atrial fibrillation who are randomized to episodic amiodarone treatment (EAT) strategy and patients who are randomized to continuous amiodarone treatment (CAT) strategy, while atrial fibrillation is still effectively suppressed.

Adverse events can be related to:

1. amiodarone use
2. atrial fibrillation itself or underlying heart disease.

Secondary objective

To determine differences in quality of life between patients with persistent atrial fibrillation who are randomized to the EAT strategy and patients who are randomized to the CAT strategy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Persistant Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

amiodarone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Symptomatic persistent atrial fibrillation for at least 48 hours- 1 year (present episode).
2. Older than 18 years of age.
3. Ventricular rate during AF \> 75 beats per minute, documented on rest-ECG without rate control.
4. At least two weeks of oral anticoagulation therapy before screening.
5. Written informed consent.

Exclusion Criteria

1. Contra indications for amiodarone (severe chronic obstructive pulmonary disease or QTc \> 440ms).
2. History of relapse of AF during adequate amiodarone treatment (i.e. adequate amiodarone and desethylamiodarone plasma levels).
3. Concomitant treatment with class I or III antiarrhythmic drugs. Amiodarone should not have been used during the last 3 months.
4. Other (non) cardiac QT prolonging drugs (if not possible to discontinue).
5. First episode of persistent atrial fibrillation.
6. More than three relapses of persistent atrial fibrillation necessitating electrical cardioversion during the last three years.
7. Known sick sinus syndrome.
8. History of second or third degree AV conduction disturbances.
9. Intraventricular conduction disturbances (QRS\> 140ms).
10. Pacemaker treatment.
11. Hemodynamically significant valvular disease.
12. Patients with heart failure with symptoms according to NYHA class III or IV.
13. Unstable angina pectoris.
14. Recent myocardial infarction (\< 3 months).
15. PTCA, CABG, other cardiac surgery or major non-cardiac surgery within the last three months.
16. History of hyperthyroidism or hypothyroidism.
17. Serious pulmonary, hepatic, haematological, metabolic, renal, gastrointestinal, CNS or psychiatric disease.
18. Pregnant and non-pregnant women who are pre-menopausal and are not practising an acceptable method of contraception.
19. Treatment with any other investigational agent.
20. Presence of any disease that is likely to shorten life expectancy to \< 1 year.
21. Any condition that in the opinion of the investigator would jeopardise the evaluation of efficacy or safety or be associated with poor adherence to the protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No