Renin-angiotensin-aldosterone System (RAAS), Inflammation, and Post-Operative Atrial Fibrillation (AF)
Atrial Fibrillation
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, cardiac surgery
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo
Ramipril
Spironolactone
matched placebo pills daily beginning 4-7 days before surgery and continuing through discharge
Ramipril daily (2.5mg, increased to 5mg) beginning 4 to 7 days before surgery and continuing through discharge
Spironolactone 25mg daily beginning 4 to 7 days before surgery and continuing through discharge