Back to resultsMagnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.
Primary Purpose
Arrhythmia, Quality of Life, Hypomagnesemia
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Magnesium L-lactate
Sponsored by
About this trial
This is an interventional treatment trial for Arrhythmia focused on measuring Implantable Cardioverter Defibrillator, Magnesium, Electrocardiogram, Ventricular Arrhythmia
Eligibility Criteria
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. -
Sites / Locations
- Hartford HospitalRecruiting
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00282620
Brief Title
Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.
Official Title
The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hartford Hospital
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Quality of Life, Hypomagnesemia
Keywords
Implantable Cardioverter Defibrillator, Magnesium, Electrocardiogram, Ventricular Arrhythmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Magnesium L-lactate
Primary Outcome Measure Information:
Title
Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months
Secondary Outcome Measure Information:
Title
Change in QTc interval in the total population and the subgroup receiving class III antiarrhythmics at baseline, 3, 6, 9, 12 months.
Title
Intracellular magnesium concentrations at baseline, 3 and 12 months
Title
Incidence of supraventricular arrhythmias, ventricular arrhythmias, and sinus tachycardias at baseline, 3,6,9,12 months.
Title
Ventricular fibrillation cycle length and the variability in VFCL at baseline, 3,6,9,12 months
Title
Adverse events at basline, 3,6,9,12 months. Total Hospital Costs and Cost-effectiveness.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Kluger, MD
Phone
860-545-2883
Email
Jkluger@harthosp.org
First Name & Middle Initial & Last Name or Official Title & Degree
Charles M White, PharmD
Phone
860-545-2221
Email
Cmwhite@harthosp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Kluger, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Kluger, MD
Phone
860-545-2883
Email
JKluger@harthosp.org
First Name & Middle Initial & Last Name & Degree
Charles M White, PharmD
Phone
860-545-2221
Email
Cmwhite@harthosp.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Kluger, MD
First Name & Middle Initial & Last Name & Degree
Charles M White, PharmD
First Name & Middle Initial & Last Name & Degree
Nickole N Henyan, PharmD
First Name & Middle Initial & Last Name & Degree
Stephen D Sander, PharmD
First Name & Middle Initial & Last Name & Degree
Craig I Coleman, PharmD
First Name & Middle Initial & Last Name & Degree
Effie L Gillespie, PharmD
First Name & Middle Initial & Last Name & Degree
Christopher A Clyne, MD
First Name & Middle Initial & Last Name & Degree
William L Baker, PharmD
12. IPD Sharing Statement
Learn more about this trial
Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life.
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