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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Hartford Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00282620
First received: January 25, 2006
Last updated: November 16, 2007
Last verified: March 2007

January 25, 2006
November 16, 2007
January 2006
Not Provided
Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months
Same as current
Complete list of historical versions of study NCT00282620 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Not Provided
Not Provided
 
Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.
The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Arrhythmia
  • Quality of Life
  • Hypomagnesemia
Drug: Magnesium L-lactate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
June 2008
Not Provided

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.

-

Both
18 Years and older
No
Contact: Jeffrey Kluger, MD 860-545-2883 Jkluger@harthosp.org
Contact: Charles M White, PharmD 860-545-2221 Cmwhite@harthosp.org
United States
 
NCT00282620
KLUG001817HE
Not Provided
Not Provided
Hartford Hospital
Not Provided
Principal Investigator: Jeffrey Kluger, MD Hartford Hospital
Hartford Hospital
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP