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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01082055
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : May 14, 2018
NHS Tayside
Information provided by (Responsible Party):
University of Dundee

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.

Condition or disease
Cardiac Dysrhythmia

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Currently receiving antiarrythmic drugs

Primary Outcome Measures :
  1. Adverse Event [ Time Frame: 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients in Tayside receiving a prescription for an anti-arrythmic drug since 1994

Inclusion Criteria:

  • At least one prescription for antiarrythmic drug

Information from the National Library of Medicine

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 identifier (NCT number): NCT01082055

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United Kingdom
Univeristy of Dundee
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
NHS Tayside
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Responsible Party: University of Dundee Identifier: NCT01082055    
Other Study ID Numbers: ELD006
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: March 2010
Keywords provided by University of Dundee:
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Cardiac Conduction System Disease
Heart Diseases
Cardiovascular Diseases
Pathologic Processes