Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00282620|
Recruitment Status : Unknown
Verified March 2007 by Hartford Hospital.
Recruitment status was: Recruiting
First Posted : January 27, 2006
Last Update Posted : November 20, 2007
|Condition or disease||Intervention/treatment||Phase|
|Arrhythmia Quality of Life Hypomagnesemia||Drug: Magnesium L-lactate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life|
|Study Start Date :||January 2006|
|Estimated Study Completion Date :||June 2008|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282620
|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|