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

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ClinicalTrials.gov Identifier: NCT01082055
Recruitment Status : Unknown
Verified March 2010 by University of Dundee.
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2010
Last Update Posted : March 5, 2010
Sponsor:
Collaborator:
NHS Tayside
Information provided by:
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

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 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

Group/Cohort
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, Senior
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01082055


Locations
United Kingdom
Univeristy of Dundee
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
NHS Tayside

Responsible Party: Dr Douglas Elder, University of Dundee
ClinicalTrials.gov Identifier: NCT01082055     History of Changes
Other Study ID Numbers: ELD006
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: March 2010

Keywords provided by University of Dundee:
Cardiac
Dysrhythmia
Safety

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes