- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03289429
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, 71515
- Recruiting
- Assiut University
-
Contact:
- Fatma N. Mohamed, M.Sc.
- Phone Number: +201003633992
- Email: fatmanabil2012@gmail.com
-
Contact:
- Esam Eldin M. Abdallah, M.D.
- Email: 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.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Atorvastatin
- Magnesium Sulfate
Other Study ID Numbers
- Statin and Magnesium
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Arrhythmias
-
Medtronic BRCCompletedAtrial Fibrillation | Risk of Cardiac ArrhythmiasNetherlands, Germany, Austria, Belgium, Canada, Czech Republic, Russian Federation, Slovakia
-
Uri farkashCompletedEvaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With AdrenalineIsrael
-
Massachusetts General HospitalTerminated
-
The Leeds Teaching Hospitals NHS TrustCompletedArrhythmiasUnited Kingdom
-
Biosense Webster, Inc.Completed
-
Medtronic Cardiac Rhythm and Heart FailureCompletedCardiac ArrhythmiasAustria, France
-
Biosense Webster, Inc.CompletedArrhythmiasCzech Republic, Belgium
-
Instituto de Investigación Sanitaria Gregorio MarañónCatheter Robotics, Inc.Unknown
Clinical Trials on Atorvastatin
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2Korea, Republic of, Malaysia, Philippines, Thailand, Russian Federation, Mexico
-
Organon and CoCompleted
-
Obafemi Awolowo University Teaching HospitalOpen PhilanthropyRecruitingTuberculosis | Pulmonary Tuberculosis | Koch's DiseaseNigeria
-
Hippocration General HospitalCompletedCoronary Artery Disease | Atherosclerosis | Endothelial Dysfunction | Oxidative Stress | HMG-CoA Reductase Inhibitor ToxicityGreece
-
Organon and CoCompleted
-
Zhejiang Hisun Pharmaceutical Co. Ltd.Unknown
-
Seoul National University HospitalDong-A PharmaceuticalCompletedCardiovascular Disease | Dyslipidemia | HypercholesterolemiaKorea, Republic of
-
PfizerCompletedHypertriglyceridemia | Hyperlipoproteinemia Type IVUnited States, Canada
-
Hanmi Pharmaceutical Company LimitedCompletedHypertension | HyperlipidemiaKorea, Republic of
-
xieruiqinCompletedAtrial FibrillationChina