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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Dundee.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
NHS Tayside
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT01082055
First received: March 4, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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
Cardiac Dysrhythmia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Adverse Event [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5000
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Currently receiving antiarrythmic drugs

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082055

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

No publications provided

Responsible Party: Dr Douglas Elder, University of Dundee
ClinicalTrials.gov Identifier: NCT01082055     History of Changes
Other Study ID Numbers: ELD006
Study First Received: March 4, 2010
Last Updated: March 4, 2010
Health Authority: United Kingdom: National Health Service
United Kingdom: University of Dundee

Keywords provided by University of Dundee:
Cardiac
Dysrhythmia
Safety

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

ClinicalTrials.gov processed this record on September 30, 2014