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

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ClinicalTrials.gov Identifier: NCT03289429
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
FATMA NABIL AHMED MOHAMED, Assiut University

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

Condition or disease Intervention/treatment Phase
Arrhythmias Drug: Atorvastatin Drug: Magnesium Sulfate Other: intravenous placebo Other: tablets placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Study of the Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery
Actual Study Start Date : September 24, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atorvastatin
Atorvastatin and intravenous placebo
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.

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.

Experimental: Magnesium sulfate
Magnesium sulfate and tablets placebo
Drug: 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: tablets placebo
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
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.

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




Primary Outcome Measures :
  1. Postoperative atrial fibrillation [ Time Frame: Five days ]
    The occurrence of postoperative atrial fibrillation (POAF)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289429


Locations
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Egypt
Assiut University Recruiting
Assiut, Egypt, 71515
Contact: Fatma N. Mohamed, M.Sc.    +201003633992    fatmanabil2012@gmail.com   
Contact: Esam Eldin M. Abdallah, M.D.       esamel_deen@yahoo.com   
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.         
Sponsors and Collaborators
Assiut University

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Responsible Party: FATMA NABIL AHMED MOHAMED, Assistant lecturer of anesthesia and intensive care, Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT03289429     History of Changes
Other Study ID Numbers: Statin and Magnesium
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by FATMA NABIL AHMED MOHAMED, Assiut University:
Atorvastatin
Magnesium sulfate
POAF
Cardiac
Valve

Additional relevant MeSH terms:
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Atorvastatin
Magnesium Sulfate
Anti-Arrhythmia Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents