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

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Arrhythmias

Treatments: Drug: Magnesium Sulfate; Drug: Atorvastatin; Other: tablets placebo; Other: intravenous placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03289429

Statin and Magnesium

Details and patient eligibility

About

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

Full description

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 3 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

Atorvastatin and intravenous placebo

Treatment:

Drug: Atorvastatin

Other: intravenous placebo

Magnesium sulfate

Experimental group

Description:

Magnesium sulfate and tablets placebo

Treatment:

Drug: Magnesium Sulfate

Other: tablets placebo

Control

Placebo Comparator group

Description:

intravenous placebo and tablet placebo

Treatment:

Other: intravenous placebo

Other: tablets placebo