Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.

Study Overview
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Brief Summary
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This study is being conducted to see if magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life.

Detailed Description
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Not all ICD shocks are for ventricular arrhythmias. Some patients receive shocks when they have arrhythmias in the atria (top chambers of the heart). These are called inapproriate shocks, but the pain is similar to the pain patients feel with an appropriate shock (a shock for a ventricular arrhythmia). This study is being conducted to determine if taking magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life. Magnesium's impact of the electrocardiogram (ECG) and intracellular magnesium concentrations will also be studied. Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the number of ICD shocks and patient perceived quality of life.

Official Title
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The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life

Conditions
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Arrhythmia, Quality of Life, Hypomagnesemia

Intervention / Treatment
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* Drug: Magnesium L-lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:newly implanted ICD or recent ICD shock (within 6 months) - Exclusion Criteria:inability to swallow, a non-cardiac disease with a survival prognosis of less than 12 months, hypermagnesemia, a creatinine clearance less than 30mL/min, lactic acidosis or systemic acidosis syndrome, or previous intolerance to magnesium L-lactate. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Magnesium L-lactate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QTc interval in the total population and the subgroup receiving class III antiarrhythmics at baseline, 3, 6, 9, 12 months. |  |  | 
| Intracellular magnesium concentrations at baseline, 3 and 12 months |  |  | 
| Incidence of supraventricular arrhythmias, ventricular arrhythmias, and sinus tachycardias at baseline, 3,6,9,12 months. |  |  | 
| Ventricular fibrillation cycle length and the variability in VFCL at baseline, 3,6,9,12 months |  |  | 
| Adverse events at basline, 3,6,9,12 months. Total Hospital Costs and Cost-effectiveness. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable Cardioverter Defibrillator, Magnesium, Electrocardiogram, Ventricular Arrhythmia