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

Arrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03289429
• Other study ID #: Statin and Magnesium
• Status: Recruiting
• Phase: Phase 4
• First received: September 15, 2017
• Last updated: February 10, 2018
• Start date: September 24, 2017
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias

Intervention

Drug:
• Atorvastatin
Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
• Magnesium Sulfate
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.

Other:
• intravenous placebo
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.
• tablets placebo
Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative atrial fibrillation	The occurrence of postoperative atrial fibrillation (POAF)	Five days