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A Retrospective Analysis of the Use of ACE-inhibitors and Angiotensin Receptor Blockers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel C. Dudley, Jr., Emory University
ClinicalTrials.gov Identifier:
NCT00321945
First received: May 1, 2006
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

It is well known that atrial fibrillation (AF) and atrial flutter occur frequently after most types of cardiac surgeries.(1-4) Postoperative AF is associated with significant morbidity, longer hospital stay, and higher related costs. Currently, it is common procedure to premedicate patients with antiarrhythmic drugs for elective cardiac surgeries. Treatments such as beta blockers, Amiodarone, and electrical pacing are used to help prevent the morbidity associated with pot-operative AF.(5)

Renin-angiotensin system (RAS) activation may contribute to AF. Several clinical trials have suggested that inhibitors of this system may reduce the incidence of AF.(6-12) Patients with AF are known to have increased levels of angiotensin converting enzyme (ACE) and some types of angiotensin receptors.(13-15) Data from animal studies performed by our group suggest that cardiac ACE overexpression may lead to arrhythmic ion channel changes.(16;17) Although not studied in this group yet, it would be reasonable to conclude that the use of ACE inhibitors and angiotensin receptor blockers (ARBs) would decrease the incidence of AF in post-operative patients, too


Condition Intervention Phase
Atrial Fibrillation
Atrial Flutter
Procedure: ACE-Inhibitors and Angiotensin Receptor Blockers
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective Analysis of the Use of ACE-inhibitors and Angiotensin Receptor Blockers on Post-Operative Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Evaluate the relationship of pre-operative ACE inhibitor or ARB use to the incidence of post-operative atrial arrhythmias. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 546
Study Start Date: December 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: ACE-Inhibitors and Angiotensin Receptor Blockers
    Retrospective study - no intervention as part of study.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients, 18 years or older up to and including 65 years of age, who underwent elective cardiac surgery in the Emory University Hospital, Crawford Long Hospital, or the VA Medical Center between 2000-2005.

Criteria

Inclusion Criteria:

  • All patients who underwent elective cardiac surgery in the Emory University Hospital, Crawford Long Hospital, or the VA Medical Center between 2000-2005.

Exclusion Criteria:

  • Emergent operations.
  • The presence of AF or atrial flutter at the time of surgery.
  • Patients without adequate documentation of atrial rhythm following surgery.
  • NYHA class IV heart failure at the time of surgery.
  • Hyperthyroidism
  • Implanted devices for designed for active management of atrial arrhythmias by pacing or defibrillation
  • Known illicit drug use
  • Known ethanol abuse
  • Electrophysiological ablation for atrial tachycardia within 6 months of the operation.
  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: NCT00321945

Locations
United States, Georgia
Crawford Long Hospital
Atlanta, Georgia, United States, 30365
Emory University Hospital
Atlanta, Georgia, United States, 30322
Veterans Administration Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Samuel C Dudley, Jr., MD, PhD Veterans Administration Medical Center
  More Information

No publications provided

Responsible Party: Samuel C. Dudley, Jr., Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00321945     History of Changes
Other Study ID Numbers: IRB00002174
Study First Received: May 1, 2006
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Atrial Fibrillation
Atrial Flutter
Angiotensin Converting Enzyme Inhibitor
Angiotensin Receptor Blocker

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014