Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
Primary Purpose
Persistant Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
amiodarone
Sponsored by
About this trial
This is an interventional treatment trial for Persistant Atrial Fibrillation
Eligibility Criteria
Inclusion criteria:
- Symptomatic persistent atrial fibrillation for at least 48 hours- 1 year (present episode).
- Older than 18 years of age.
- Ventricular rate during AF > 75 beats per minute, documented on rest-ECG without rate control.
- At least two weeks of oral anticoagulation therapy before screening.
- Written informed consent.
Exclusion criteria:
- Contra indications for amiodarone (severe chronic obstructive pulmonary disease or QTc > 440ms).
- History of relapse of AF during adequate amiodarone treatment (i.e. adequate amiodarone and desethylamiodarone plasma levels).
- Concomitant treatment with class I or III antiarrhythmic drugs. Amiodarone should not have been used during the last 3 months.
- Other (non) cardiac QT prolonging drugs (if not possible to discontinue).
- First episode of persistent atrial fibrillation.
- More than three relapses of persistent atrial fibrillation necessitating electrical cardioversion during the last three years.
- Known sick sinus syndrome.
- History of second or third degree AV conduction disturbances.
- Intraventricular conduction disturbances (QRS> 140ms).
- Pacemaker treatment.
- Hemodynamically significant valvular disease.
- Patients with heart failure with symptoms according to NYHA class III or IV.
- Unstable angina pectoris.
- Recent myocardial infarction (< 3 months).
- PTCA, CABG, other cardiac surgery or major non-cardiac surgery within the last three months.
- History of hyperthyroidism or hypothyroidism.
- Serious pulmonary, hepatic, haematological, metabolic, renal, gastrointestinal, CNS or psychiatric disease.
- Pregnant and non-pregnant women who are pre-menopausal and are not practising an acceptable method of contraception.
- Treatment with any other investigational agent.
- Presence of any disease that is likely to shorten life expectancy to < 1 year.
- 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.
Sites / Locations
- University Medical Center Groningen
Outcomes
Primary Outcome Measures
Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease
Secondary Outcome Measures
Quality of life
Number of patients with permanent AF at the end of the study
Full Information
NCT ID
NCT00392431
First Posted
October 25, 2006
Last Updated
March 21, 2007
Sponsor
University Medical Center Groningen
Collaborators
Netherlands Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00392431
Brief Title
Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
Official Title
Continuous Versus Episodic Prophylactic Treatment With Oral Amiodarone for the Prevention of Permanent Atrial Fibrillation: a Randomized Study on Morbidity and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Medical Center Groningen
Collaborators
Netherlands Heart Foundation
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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:
amiodarone use
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistant Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
amiodarone
Primary Outcome Measure Information:
Title
Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease
Secondary Outcome Measure Information:
Title
Quality of life
Title
Number of patients with permanent AF at the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Symptomatic persistent atrial fibrillation for at least 48 hours- 1 year (present episode).
Older than 18 years of age.
Ventricular rate during AF > 75 beats per minute, documented on rest-ECG without rate control.
At least two weeks of oral anticoagulation therapy before screening.
Written informed consent.
Exclusion criteria:
Contra indications for amiodarone (severe chronic obstructive pulmonary disease or QTc > 440ms).
History of relapse of AF during adequate amiodarone treatment (i.e. adequate amiodarone and desethylamiodarone plasma levels).
Concomitant treatment with class I or III antiarrhythmic drugs. Amiodarone should not have been used during the last 3 months.
Other (non) cardiac QT prolonging drugs (if not possible to discontinue).
First episode of persistent atrial fibrillation.
More than three relapses of persistent atrial fibrillation necessitating electrical cardioversion during the last three years.
Known sick sinus syndrome.
History of second or third degree AV conduction disturbances.
Intraventricular conduction disturbances (QRS> 140ms).
Pacemaker treatment.
Hemodynamically significant valvular disease.
Patients with heart failure with symptoms according to NYHA class III or IV.
Unstable angina pectoris.
Recent myocardial infarction (< 3 months).
PTCA, CABG, other cardiac surgery or major non-cardiac surgery within the last three months.
History of hyperthyroidism or hypothyroidism.
Serious pulmonary, hepatic, haematological, metabolic, renal, gastrointestinal, CNS or psychiatric disease.
Pregnant and non-pregnant women who are pre-menopausal and are not practising an acceptable method of contraception.
Treatment with any other investigational agent.
Presence of any disease that is likely to shorten life expectancy to < 1 year.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle C Van Gelder, MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
20200016
Citation
Ahmed S, Ranchor AV, Crijns HJ, Van Veldhuisen DJ, Van Gelder IC; CONVERT investigators. Effect of continuous versus episodic amiodarone treatment on quality of life in persistent atrial fibrillation. Europace. 2010 Jun;12(6):785-91. doi: 10.1093/europace/euq049. Epub 2010 Mar 2.
Results Reference
derived
PubMed Identifier
18854540
Citation
Ahmed S, Rienstra M, Crijns HJ, Links TP, Wiesfeld AC, Hillege HL, Bosker HA, Lok DJ, Van Veldhuisen DJ, Van Gelder IC; CONVERT Investigators. Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation: a randomized trial. JAMA. 2008 Oct 15;300(15):1784-92. doi: 10.1001/jama.300.15.1784.
Results Reference
derived
Learn more about this trial
Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
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