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

February 10, 2018 updated by: FATMA NABIL AHMED MOHAMED, Assiut University

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

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

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt, 71515
        • Recruiting
        • Assiut University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fatma N. Mohamed, M.Sc.
        • Principal Investigator:
          • Esam Eldin M. Abdallah, M.D.
        • Principal Investigator:
          • Abdelrady S. Ibrahim, M.D.
        • Principal Investigator:
          • Ahmed El-Minshawy, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Atorvastatin
Atorvastatin and intravenous placebo
Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
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.
EXPERIMENTAL: Magnesium sulfate
Magnesium sulfate and tablets placebo
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.
Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
PLACEBO_COMPARATOR: Control
intravenous placebo and tablet 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.
Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative atrial fibrillation
Time Frame: Five days
The occurrence of postoperative atrial fibrillation (POAF)
Five days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 24, 2017

Primary Completion (ANTICIPATED)

February 1, 2018

Study Completion (ANTICIPATED)

February 1, 2018

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (ACTUAL)

September 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 10, 2018

Last Verified

February 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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