Antiarrythmic Drugs - Long-term Follow-up in the Modern Era
Retrospective Record Linkage Study to Investigate the Incidence of Complications and Follow-up Associated With Anti-arrythmic Drug Therapy
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMay 14, 2018
March 1, 2010
6 years
March 4, 2010
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Event
10 years
Study Arms (1)
Currently receiving antiarrythmic drugs
Eligibility Criteria
All patients in Tayside receiving a prescription for an anti-arrythmic drug since 1994
You may qualify if:
- At least one prescription for antiarrythmic drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Dundeelead
- NHS Taysidecollaborator
Study Sites (1)
Univeristy of Dundee
Dundee, DD1 9SY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
May 14, 2018
Record last verified: 2010-03