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

Primary Purpose

Arrhythmias

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Atorvastatin

Magnesium Sulfate

intravenous placebo

tablets placebo

About this trial

This is an interventional prevention trial for Arrhythmias focused on measuring Atorvastatin, Magnesium sulfate, POAF, Cardiac, Valve

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Atorvastatin

Magnesium sulfate

Control

Arm Description

Atorvastatin and intravenous placebo

Magnesium sulfate and tablets placebo

intravenous placebo and tablet placebo

Outcomes

Primary Outcome Measures

Postoperative atrial fibrillation

The occurrence of postoperative atrial fibrillation (POAF)

Secondary Outcome Measures

Full Information

NCT ID

NCT03289429

First Posted

September 15, 2017

Last Updated

February 10, 2018

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03289429

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 24, 2017 (Actual)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arrhythmias

Keywords

Atorvastatin, Magnesium sulfate, POAF, Cardiac, Valve

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin

Arm Type

Experimental

Arm Description

Atorvastatin and intravenous placebo

Arm Title

Magnesium sulfate

Arm Type

Experimental

Arm Description

Magnesium sulfate and tablets placebo

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

intravenous placebo and tablet placebo

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Magnesium Sulfate

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

intravenous placebo

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

tablets placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative atrial fibrillation

Description

The occurrence of postoperative atrial fibrillation (POAF)

Time Frame

Five days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Assiut University

City

Assiut

ZIP/Postal Code

71515

Country

Egypt

Individual Site Status

Recruiting

Facility Contact: