A Retrospective Analysis of the Use of ACE-Inhibitors and Angiotensin Receptor Blockers - Full Text View

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
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 Surgery

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
Veterans Administration Medical Center
Decatur, Georgia, United States, 30033
Crawford Long Hospital
Atlanta, Georgia, United States, 30365
Emory University Hospital
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Samuel C Dudley, Jr., MD, PhD

Veterans Administration Medical Center

More Information

No publications provided

Study ID Numbers:	1307-2005
Study First Received:	May 1, 2006
Last Updated:	April 10, 2007
ClinicalTrials.gov Identifier:	NCT00321945 History of Changes
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:

Pathologic Processes
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases

Atrial Fibrillation
Pharmacologic Actions
Atrial Flutter
Protease Inhibitors
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010