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

Phase 4

• Conditions: Arrhythmias
• Interventions: Drug: Atorvastatin; Drug: Magnesium Sulfate; Other: intravenous placebo; Other: tablets placebo

• Registration Number: NCT03289429
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Study Start: 2017-09-24
• Status Verified: 2018-02
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-02-10
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	intravenous placebo	Atorvastatin and intravenous placebo
Control	intravenous placebo	intravenous placebo and tablet placebo
Magnesium sulfate	tablets placebo	Magnesium sulfate and tablets placebo
Control	tablets placebo	intravenous placebo and tablet placebo
Atorvastatin	Atorvastatin	Atorvastatin and intravenous placebo
Magnesium sulfate	Magnesium Sulfate	Magnesium sulfate and tablets placebo

Primary Outcome Measures

Name	Time	Method
Postoperative atrial fibrillation	Five days	The occurrence of postoperative atrial fibrillation (POAF)

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt