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

NCT ID: NCT01082055

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-01
• Study Completion Date: 2016-03-01

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.

Conditions

Cardiac Dysrhythmia

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Currently receiving antiarrythmic drugs

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• At least one prescription for antiarrythmic drug

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Tayside

OTHER_GOV

Sponsor Role: collaborator

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Univeristy of Dundee

Dundee, , United Kingdom

Countries

United Kingdom

Other Identifiers

ELD006

Identifier Type: -

Identifier Source: org_study_id