Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery

Study Overview
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Brief Summary
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This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus Magnesium Sulfate after Cardiac valve Replacement Surgery

Detailed Description
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Arrhythmia is a common complication after cardiac valve surgery. Postoperative atrial fibrillation (POAF) is the most common type of arrhythmia after cardiac surgery. It has different leading causes, including myocardial injury, inadequate myocardial protection, the effect of cardiopulmonary bypass, and electrolyte imbalance. Beta blockers, amiodarone, and magnesium sulfate are used for the management of POAF. Statin is used commonly for its lipid lowering action, however, some studies shows that statin has powerful pleiotropic effects including its antiarrhythmic effect. This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus magnesium sulfate after cardiac replacement surgery.

Official Title
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Comparative Study of the Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery

Conditions
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Arrhythmias

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Magnesium Sulfate
* Other: intravenous placebo
* Other: tablets placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing isolated valvular replacement surgery. Preoperative rhythm: Sinus rhythm. Preoperative troponin I < 0.01 ng/mL. Normal lipid profile. White blood cells (4-11 X 103/mm3). Preoperative C-reactive protein < 3 mg/L. Exclusion Criteria: History of atrial fibrillation. Any degree of heart block or patients with implanted pacemaker. Prior use of Antiarrhythmic drugs. Preoperative lipid lowering therapy (e.g statins) during the last 3 months. Previous treatment with any type of magnesium containing supplementation (the week before the intervention). Underlying heart failure or Left ventricular ejection fraction < 0.3. Previous myocardial infarction. Diabetes or other metabolic disorders. Renal diseases. Hepatic dysfunction. Underlying thyroid problems (hypo/hyperthyroidism). Underlying inflammatory disease (active or controlled) Immunosuppressive and anti-inflammatory medications for the treatment of coexisting conditions. Psychological disorders, Emergency cardiac surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>Atorvastatin and intravenous placebo | Drug: Atorvastatin<br>* Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.<br>Other: intravenous placebo<br>* 100 mL of isotonic saline (to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.<br>|
| Experimental: Magnesium sulfate<br>Magnesium sulfate and tablets placebo | Drug: Magnesium Sulfate<br>* Magnesium sulfate: ( 3 grams dissolved in 100 mL of isotonic saline to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.<br>Other: tablets placebo<br>* Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.<br>|
| Placebo Comparator: Control<br>intravenous placebo and tablet placebo | Other: intravenous placebo<br>* 100 mL of isotonic saline (to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.<br>Other: tablets placebo<br>* Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative atrial fibrillation | The occurrence of postoperative atrial fibrillation (POAF) | Five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atorvastatin, Magnesium sulfate, POAF, Cardiac, Valve