Renin-angiotensin-aldosterone System (RAAS), Inflammation, and Post-Operative Atrial Fibrillation (AF)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

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 hospital stay, complicates 20% to 40% of cardiopulmonary bypass (CPB) surgical procedures. While recent studies indicate that interruption of the renin-angiotensin-aldosterone system by either angiotensin-converting enzyme (ACE) inhibition or AT1 receptor antagonism decreases the incidence of AF following a heart attack or cardioversion (electric shock to the heart), its effect on the incidence of post-operative AF has not been throughly studied. Studies in both animals and humans suggest that inflammation-induced atrial remodeling plays an important role in the cause of AF. Recent studies also provide evidence that activation of the renin-angiotensin-aldosterone system induces inflammation, myocyte injury, proarrhythmic electrical remodeling, and fibrosis through aldosterone.

Key facts

Study ID

NCT00141778

Run by

Vanderbilt University

People needed

455

Starts

2005-04-01

Expected to finish

2010-08-01

Last updated by the study team

2013-03-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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