Atrial FibrillationPhase 3NCT00965874
Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation
A Phase 3 study testing Magnesium Sulfate high dose and Magnesium Sulfate low dose in people with Atrial Fibrillation, run by University of Monastir at 1 site in Tunisia.
Trial summary
Objective: To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the immediate treatment of rapid AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Magnesium Sulfate high dose and Magnesium Sulfate low dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteTunisia
- Study dates
- Nov 2009to Aug 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients presenting to ED with rapid AF (Heart rate >120 bpm).
Who cannot join
- Unstable hemodynamic state.
- Renal insufficiency (creatinemia> 180 µmol/l).
- Allergy to MgS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation : Randomised Controlled Double Blind Study (LOMAGHI Study)
Objective:
To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the immediate treatment of rapid AF.
Read the detailed description
Introduction:
Atrial fibrillation (AF) is a potentially life-threatening cardiac arrhythmia and a frequent chief complaint in emergency departments (ED). It is an important concern for a substantial proportion of people worldwide. According to the Rotterdam study, the prevalence of AF among individuals aged between 55 to 59 years is estimated at 1.1 for 1000 persons/year and 20.7 for individuals between 80 and 84 years. Given current adult advanced cardiac life support (ACLS), the immediate clinical objective in rapid AF is to achieve ventricular rate control. Digoxin, beta blockers and calcium channel antagonists are the most widely used agents for the emergent treatment of rapid AF. However, their effect is limited because only half of the patients will acutely respond to the first intention treatment. Several studies showed that the magnesium sulfate (MgS) is beneficial in the control of the rate and the rhythm of AF. In addition, hypomagnesemia is present among patients having AF in 20 to 53% of the cases . The association of hypomagnesemia and AF is common after a cardiac surgery and the prophylactic administration of MgS could be useful in post-operative AF .
The last meta analysis published in 2007 showed that the MgS is as well efficient in rate control (OR = 1.96) as in rhythm control (OR = 1.60) of AF. However most studies included in this meta analysis were conducted on limited number of patients (303 patients included for rate control outcome analysis and 376 for rhythm control). Consequently we need further randomized controlled studies to establish definitively the efficacy and the safety of MgS in the early management of rapid AF.
Objective:
To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the immediate treatment of rapid AF.
- Conditions
- Atrial Fibrillation
- Being tested
- Magnesium Sulfate high dose, Magnesium Sulfate low dose, Placebos
- Keywords
- Rapid Atrial Fibrillation, Magnesium Sulfate, Cardiac arrhythmia
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate high doseDrug
Also called Magnesium Sulfate
9 g infusion once during 30 minutes
Magnesium Sulfate low doseDrug
Also called Magnesium Sulfate
4.5 g magnesium sulfate infusion
PlacebosDrug
serum salin
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate high dose infusion | Experimental | 9 g Magnesium sulfate infusion over 30 minutes Receives: Drug: Magnesium Sulfate high dose |
| Magnesium Sulfate low dose infusion | Active comparator | 4.5 magnesium sulfate infusion over 30 minutes Receives: Drug: Magnesium Sulfate low dose |
| placebo | Placebo comparator | serum salin Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
HR <90 bpm or 20% reduction from baseline at 24 hours
Measured: 24 hours
Secondary outcomes (1)
Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- nouira semir, MD, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965874
- Sponsor's protocol ID
- LOMAGHI
- Status last verified
- Apr 2018
- First submitted
- 24 Aug 2009
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Versus High Dose Magnesium Sulfate in the Early Management of Rapid Atrial Fibrillation : Randomised Controlled Double Blind Study (LOMAGHI Study)
- ClinicalTrials.gov ID
- NCT00965874
- Acronym / sponsor ID
- LOMAGHI
- Conditions
- Atrial Fibrillation
- Keywords
- Rapid Atrial Fibrillation, Magnesium Sulfate, Cardiac arrhythmia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Aug 2009 (estimated)
- 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.
Objective:
To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the immediate treatment of rapid AF.
Detailed description
Introduction:
Atrial fibrillation (AF) is a potentially life-threatening cardiac arrhythmia and a frequent chief complaint in emergency departments (ED). It is an important concern for a substantial proportion of people worldwide. According to the Rotterdam study, the prevalence of AF among individuals aged between 55 to 59 years is estimated at 1.1 for 1000 persons/year and 20.7 for individuals between 80 and 84 years. Given current adult advanced cardiac life support (ACLS), the immediate clinical objective in rapid AF is to achieve ventricular rate control. Digoxin, beta blockers and calcium channel antagonists are the most widely used agents for the emergent treatment of rapid AF. However, their effect is limited because only half of the patients will acutely respond to the first intention treatment. Several studies showed that the magnesium sulfate (MgS) is beneficial in the control of the rate and the rhythm of AF. In addition, hypomagnesemia is present among patients having AF in 20 to 53% of the cases . The association of hypomagnesemia and AF is common after a cardiac surgery and the prophylactic administration of MgS could be useful in post-operative AF .
The last meta analysis published in 2007 showed that the MgS is as well efficient in rate control (OR = 1.96) as in rhythm control (OR = 1.60) of AF. However most studies included in this meta analysis were conducted on limited number of patients (303 patients included for rate control outcome analysis and 376 for rhythm control). Consequently we need further randomized controlled studies to establish definitively the efficacy and the safety of MgS in the early management of rapid AF.
Objective:
To assess the efficacy and the safety of high (9g) and low dose (4.5g) of MgS in the immediate treatment of rapid AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate high dose infusion | Experimental | Drug: Magnesium Sulfate high dose9 g Magnesium sulfate infusion over 30 minutes |
| Magnesium Sulfate low dose infusion | Active comparator | Drug: Magnesium Sulfate low dose4.5 magnesium sulfate infusion over 30 minutes |
| placebo | Placebo comparator | Drug: Placebosserum salin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presenting to ED with rapid AF (Heart rate >120 bpm).
Key exclusion criteria (3 listed)
- Unstable hemodynamic state.
- Renal insufficiency (creatinemia> 180 µmol/l).
- Allergy to MgS.
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 |
|---|---|---|
| Magnesium Sulfate high doseAlso: Magnesium Sulfate9 g infusion once during 30 minutes | Drug | Magnesium Sulfate high dose infusion |
| Magnesium Sulfate low doseAlso: Magnesium Sulfate4.5 g magnesium sulfate infusion | Drug | Magnesium Sulfate low dose infusion |
| Placebosserum salin | Drug | placebo |
Primary outcome
HR <90 bpm or 20% reduction from baseline at 24 hours
Time frame: 24 hours
1 secondary outcome
Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: Yes
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Atrial Fibrillation (AF)
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.
nouira semir, MD principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium Sulfate high dose and Magnesium Sulfate low dose in people with Atrial Fibrillation, run by University of Monastir at 1 site in Tunisia.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 20 Apr 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 Tunisia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HR <90 bpm or 20% reduction from baseline at 24 hours (time frame: 24 hours). 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 20 Apr 2018.