Withdrawal Versus Continuation of Amiodarone in Successfu... | NCT00845780

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

NCT00845780

Sponsor

University Medical Center Groningen

Status

Completed

Last Update Posted

Jun 24, 2009Estimated

Enrollment

37Actual

Phase

Phase 4

Conditions

Persistent Atrial Fibrillation

Interventions

withdrawal or continuation of amiodarone therapy

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2000

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 17, 2009

First Posted Date

Feb 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2009

Last Update Posted Date

Jun 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of persistent atrial fibrillation. It can however cause many adverse events, both cardiac and non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult especially because of high recurrence rates during the first month after cardioversion. Duration of atrial fibrillation, type of underlying disease, left ventricular function, left atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial fibrillation may be related to a highly arrhythmogenic period due to recovery from electrical remodelling. Late recurrences may be related to other triggers than recovery from electrical remodelling. In this study the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of late relapses of persistent atrial fibrillation. Furthermore, the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of amiodarone related adverse events as well as adverse events related to atrial fibrillation or underlying heart disease. The investigators also want to investigate which patients characteristics are and potential triggers have a prognostic value in the occurence of late relapses after amiodarone withdrawal.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
withdrawal amiodarone	Experimental	withdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy	Drug: withdrawal or continuation of amiodarone therapy
continuation amiodarone	Active Comparator	continuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy	Drug: withdrawal or continuation of amiodarone therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
withdrawal or continuation of amiodarone therapy	Drug	withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy	continuation amiodarone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
occurrence of late relapse of persistent atrial fibrillation		2 years

Secondary Outcomes

Measure	Description	Time Frame
difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

history of persistent atrial fibrillation, necessitating at least one electrical cardioversion
presence of sinus rhythm during the last 6 months, while on amiodarone treatment without adverse events related to amiodarone
clinically stable
age > 18 years
written informed consent

Exclusion Criteria:

sinus rhythm maintenance is preferable (because of atrial fibrillation related morbidity or any other reason)
symptomatic heart failure NYHA III or IV
unstable angina pectoris
hemodynamically significant valvular disease
concomitant treatment with other class I or III antiarrhythmic drug
PCI,CABG, other cardiac surgery or major non-cardiac surgery within the last three months
recent myocardial infarction (< 3 months)
presence of any disease that is likely to shorten life expectancy to < 1 year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle C. Van Gelder, MD PhD	University Medical Center Groningen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen		Groningen	Provincie Groningen	9700 RB	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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