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Clinical Trials/NCT01082055
NCT01082055
Completed
Not Applicable

Retrospective Record Linkage Study to Investigate the Incidence of Complications and Follow-up Associated With Anti-arrythmic Drug Therapy

University of Dundee1 site in 1 country5,000 target enrollmentMarch 1, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Dysrhythmia
Sponsor
University of Dundee
Enrollment
5000
Locations
1
Primary Endpoint
Adverse Event
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Antiarrhythmic drugs are associated with significant side effect profiles. Amiodarone has primarily class III action and whilst it has unrivalled efficacy in management of certain arrhythmias, it has a formidable side effect profile. Complications of continued therapy include, thyroiditis, hepatitis, cholestasis, increased skin sensitivity and pulmonary fibrosis. Current prescribing guidelines recommend frequent blood tests to monitor kidney, liver and thyroid function, in addition to frequent pulmonary function tests. Sotalol is a betablocker which possesses class III action in high doses and may predispose to QT prolongation Other class I agents such as flecainide and propafenone can be associated with sudden cardiac death in certain populations, and may predispose to other arrhythmias.

This study will examine the incidence of discontinuation of AAD therapy and adverse events.

Registry
clinicaltrials.gov
Start Date
March 1, 2010
End Date
March 1, 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least one prescription for antiarrythmic drug

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Adverse Event

Time Frame: 10 years

Study Sites (1)

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