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

November 16, 2007 updated by: Hartford Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Drug: Magnesium L-lactate

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

Interventional

Enrollment (Anticipated)

240

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

Principal Investigator: Jeffrey Kluger, MD, Hartford Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

January 25, 2006

First Submitted That Met QC Criteria

January 25, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Estimate)

November 20, 2007

Last Update Submitted That Met QC Criteria

November 16, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

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.