NCT00965874

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3 atrial-fibrillation

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

4.4 years

First QC Date

August 24, 2009

Last Update Submit

April 18, 2018

Conditions

Atrial Fibrillation

Keywords

Rapid Atrial FibrillationMagnesium SulfateCardiac arrhythmia

Outcome Measures

Primary Outcomes (1)

  • HR <90 bpm or 20% reduction from baseline at 24 hours

    24 hours

Secondary Outcomes (1)

  • Arterial hypotension Bradycardia (HR <45 bpm) Other (chest pain, allergic reaction……)

    24 hours

Study Arms (3)

Magnesium Sulfate high dose infusion

EXPERIMENTAL

9 g Magnesium sulfate infusion over 30 minutes

Drug: Magnesium Sulfate high dose

Magnesium Sulfate low dose infusion

ACTIVE COMPARATOR

4.5 magnesium sulfate infusion over 30 minutes

Drug: Magnesium Sulfate low dose

placebo

PLACEBO COMPARATOR

serum salin

Drug: Placebos

Interventions

Magnesium Sulfate high doseDRUG

9 g infusion once during 30 minutes

Also known as: Magnesium Sulfate
Magnesium Sulfate high dose infusion
Magnesium Sulfate low doseDRUG

4.5 g magnesium sulfate infusion

Also known as: Magnesium Sulfate
Magnesium Sulfate low dose infusion
PlacebosDRUG

serum salin

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients presenting to ED with rapid AF (Heart rate \>120 bpm).

You may not qualify if:

  • Unstable hemodynamic state.
  • Renal insufficiency (creatinemia\> 180 µmol/l).
  • Allergy to MgS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Monastir

Monastir, Monstir, 5000, Tunisia

Location

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • nouira semir, MD

    University of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 26, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

Locations

TU(1)