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A Retrospective Analysis of the Use of ACE-Inhibitors and Angiotensin Receptor Blockers
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Emory University.   Recruitment status was  Active, not recruiting

First Received on May 1, 2006.   Last Updated on April 10, 2007   History of Changes
Sponsor: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00321945
  Purpose

It is well known that atrial fibrillation (AF) and atrial flutter (Aflut) 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: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Atrial Fibrillation
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • This study will be a retrospective cohort analysis of all patients that underwent elective cardiac
  • surgeries between 2000-2005 at Emory University Hospital, Crawford Long Hospital, or the
  • Atlanta Veterans Affairs Medical Center to evaluate the relationship of pre-operative ACE
  • inhibitor or ARB use to the incidence of post-operative atrial arrhythmias.

Estimated Enrollment: 600
Study Start Date: December 2005
Estimated Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Aflut 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
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

ClinicalTrials.gov Identifier: NCT00321945     History of Changes
Other Study ID Numbers: 1307-2005
Study First Received: May 1, 2006
Last Updated: April 10, 2007
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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012



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