Overview

This trial is active, not recruiting.

Condition cardiac dysrhythmia
Sponsor University of Dundee
Collaborator NHS Tayside
Start date March 2010
End date March 2011
Trial size 5000 participants
Trial identifier NCT01082055, ELD006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective retrospective
Arm

Primary Outcomes

Measure
Adverse Event
time frame: 10 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - At least one prescription for antiarrythmic drug

Additional Information

Official title Retrospective Record Linkage Study to Investigate the Incidence of Complications and Follow-up Associated With Anti-arrythmic Drug Therapy
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by University of Dundee.