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

May 8, 2018 updated by: University of Dundee

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients in Tayside receiving a prescription for an anti-arrythmic drug since 1994

Description

Inclusion Criteria:

  • At least one prescription for antiarrythmic drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Currently receiving antiarrythmic drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Event
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Collaborators

NHS Tayside

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELD006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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