Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.
Recruitment status was Recruiting
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.
Quality of Life
Drug: Magnesium L-lactate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life|
- Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months
- 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.
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||June 2008|
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.
|Contact: Jeffrey Kluger, MD||860-545-2883||Jkluger@harthosp.org|
|Contact: Charles M White, PharmD||860-545-2221||Cmwhite@harthosp.org|
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102-5037|
|Contact: Jeffrey Kluger, MD 860-545-2883 JKluger@harthosp.org|
|Contact: Charles M White, PharmD 860-545-2221 Cmwhite@harthosp.org|
|Principal Investigator: Jeffrey Kluger, MD|
|Sub-Investigator: Charles M White, PharmD|
|Sub-Investigator: Nickole N Henyan, PharmD|
|Sub-Investigator: Stephen D Sander, PharmD|
|Sub-Investigator: Craig I Coleman, PharmD|
|Sub-Investigator: Effie L Gillespie, PharmD|
|Sub-Investigator: Christopher A Clyne, MD|
|Sub-Investigator: William L Baker, PharmD|
|Principal Investigator:||Jeffrey Kluger, MD||Hartford Hospital|