NCT01082055

Antiarrythmic Drugs - Long-term Follow-up in the Modern Era

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: University of Dundee · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Dysrhythmia

Timeline

• Start date: 2010-03-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2010-03-05
• Last updated: 2018-05-14

Locations

1 site across 1 country: United Kingdom