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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Hartford Hospital.
Recruitment status was:  Recruiting
Information provided by:
Hartford Hospital Identifier:
First received: January 25, 2006
Last updated: November 16, 2007
Last verified: March 2007
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.

Condition Intervention Phase
Quality of Life
Drug: Magnesium L-lactate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life

Resource links provided by NLM:

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 240
Study Start Date: January 2006
Estimated Study Completion Date: June 2008
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00282620

Contact: Jeffrey Kluger, MD 860-545-2883
Contact: Charles M White, PharmD 860-545-2221

United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102-5037
Contact: Jeffrey Kluger, MD    860-545-2883   
Contact: Charles M White, PharmD    860-545-2221   
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         
Sponsors and Collaborators
Hartford Hospital
Principal Investigator: Jeffrey Kluger, MD Hartford Hospital
  More Information Identifier: NCT00282620     History of Changes
Other Study ID Numbers: KLUG001817HE
Study First Received: January 25, 2006
Last Updated: November 16, 2007

Keywords provided by Hartford Hospital:
Implantable Cardioverter Defibrillator
Ventricular Arrhythmia processed this record on May 25, 2017