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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03289429

Enrollment

Registered

2017-09-21

Start date

2017-09-24

Completion date

2018-02-28

Last updated

2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias

Keywords

Atorvastatin, Magnesium sulfate, POAF, Cardiac, Valve

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.

Interventions

DRUGAtorvastatin

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

DRUGMagnesium 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.

OTHERintravenous 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.

OTHERtablets placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026