ArrhythmiasPhase 4NCT03289429
Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery
A Phase 4 study testing Atorvastatin and Magnesium Sulfate in people with Arrhythmias, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus Magnesium Sulfate after Cardiac valve Replacement Surgery Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Arrhythmias
- What is being tested?
- Atorvastatin and Magnesium Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Sep 2017to Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Fatma N. Mohamed, M.Sc., +201003633992, fatmanabil2012@gmail.com
Esam Eldin M. Abdallah, M.D., esamel_deen@yahoo.com
About this study
Official title: 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
Read the 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.
- Conditions
- Arrhythmias
- Being tested
- Atorvastatin, Magnesium Sulfate, intravenous placebo, tablets placebo
- Keywords
- Atorvastatin, Magnesium sulfate, POAF, Cardiac, Valve
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
Magnesium SulfateDrug
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.
intravenous placeboOther
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.
tablets placeboOther
Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Atorvastatin and intravenous placebo Receives: Drug: Atorvastatin; Other: intravenous placebo |
| Magnesium sulfate | Experimental | Magnesium sulfate and tablets placebo Receives: Drug: Magnesium Sulfate; Other: tablets placebo |
| Control | Placebo comparator | intravenous placebo and tablet placebo Receives: Other: intravenous placebo; Other: tablets placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atrial fibrillation
The occurrence of postoperative atrial fibrillation (POAF)
Measured: Five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start24 Sep 2017
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA NABIL AHMED MOHAMED, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289429
- Sponsor's protocol ID
- Statin and Magnesium
- Status last verified
- Feb 2018
- First submitted
- 15 Sep 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT03289429
- Acronym / sponsor ID
- Statin and Magnesium
- Conditions
- Arrhythmias
- Keywords
- Atorvastatin, Magnesium sulfate, POAF, Cardiac, Valve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Sep 2017 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin, Other: intravenous placeboAtorvastatin and intravenous placebo |
| Magnesium sulfate | Experimental | Drug: Magnesium Sulfate, Other: tablets placeboMagnesium sulfate and tablets placebo |
| Control | Placebo comparator | Other: intravenous placebo, Other: tablets placebointravenous placebo and tablet placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAtorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days. | Drug | Atorvastatin |
| Magnesium SulfateMagnesium 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. | Drug | Magnesium sulfate |
| intravenous placebo100 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 | Atorvastatin, Control |
| tablets placeboPlacebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days. | Other | Control, Magnesium sulfate |
Primary outcome
Postoperative atrial fibrillation
Time frame: Five days
The occurrence of postoperative atrial fibrillation (POAF)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin and Magnesium Sulfate in people with Arrhythmias, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative atrial fibrillation (time frame: Five days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.