Antiarrythmic Drugs - Long-term Follow-up in the Modern Era
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|ClinicalTrials.gov Identifier: NCT01082055|
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : May 14, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Retrospective Record Linkage Study to Investigate the Incidence of Complications and Follow-up Associated With Anti-arrythmic Drug Therapy|
|Study Start Date :||March 1, 2010|
|Actual Primary Completion Date :||March 1, 2016|
|Actual Study Completion Date :||March 1, 2016|
|Currently receiving antiarrythmic drugs|
- Adverse Event [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082055
|Univeristy of Dundee|
|Dundee, United Kingdom, DD1 9SY|