Status:
COMPLETED
Renin-angiotensin-aldosterone System (RAAS), Inflammation, and Post-Operative Atrial Fibrillation (AF)
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Atrial fibrillation (AF) is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative AF, which leads to significant morbidity and a prolonged hosp...
Detailed Description
AF is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative atrial fibrillation(AF), which leads to significant morbidity and a prolonged hospi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Undergoing elective valvular heart surgery, coronary artery bypass grafting
- If female, must be postmenopausal for at least 1 year, status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and willing to undergo urine beta-hcg testing prior to drug treatment and throughout the study
- Exclusion Criteria
- History of AF other than remote paroxysmal AF
- Ejection fraction less than 30%
- Evidence of coagulopathy (INR greater than 1.7 without warfarin therapy)
- Emergency surgery
- History of ACE inhibitor-induced angioedema
- Low blood pressure (systolic blood pressure less than 100 mmHg and evidence of hypoperfusion)
- Hyperkalemia (potassium level greater than 5.0 milliequivalents (mEq)/L at study entry)
- Impaired kidney function (serum creatinine level greater than 1.6 mg/dl)
- Any underlying or acute disease requiring regular medication that could possibly cause complications or make implementation of the study or interpretation of the study results difficult
- Inability to discontinue current ACE inhibitor, AT1 receptor antagonist, or aldosterone receptor antagonist therapy
- History of alcohol or drug abuse
- Treatment with any investigational drug in the month prior to study entry
- Mental condition that makes it impossible to understand the nature, scope and possible consequences of the study
- Inability to comply with the study procedures (e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study)
- Pregnant or breastfeeding
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT00141778
Start Date
April 1 2005
End Date
August 1 2010
Last Update
March 22 2013
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232