- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282620
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jeffrey Kluger, MD
- Phone Number: 860-545-2883
- Email: JKluger@harthosp.org
Study Contact Backup
- Name: Charles M White, PharmD
- Phone Number: 860-545-2221
- Email: Cmwhite@harthosp.org
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06102-5037
- Recruiting
- Hartford Hospital
-
Contact:
- Jeffrey Kluger, MD
- Phone Number: 860-545-2883
- Email: JKluger@harthosp.org
-
Contact:
- Charles M White, PharmD
- Phone Number: 860-545-2221
- Email: 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
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey Kluger, MD, Hartford Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KLUG001817HE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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