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

Cardiac Dysrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082055
• Other study ID #: ELD006
• Status: Completed
• Start date: March 1, 2010
• Est. completion date: March 1, 2016

Study information

• Verified date: March 2010
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• At least one prescription for antiarrythmic drug

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Dysrhythmia

Locations

Country	Name	City	State
United Kingdom	Univeristy of Dundee	Dundee

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event		10 years