Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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
Arrhythmia
Quality of Life
Hypomagnesemia
Drug: Magnesium L-lactate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282620

Contacts
Contact: Jeffrey Kluger, MD 860-545-2883 Jkluger@harthosp.org
Contact: Charles M White, PharmD 860-545-2221 Cmwhite@harthosp.org

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102-5037
Contact: Jeffrey Kluger, MD    860-545-2883    JKluger@harthosp.org   
Contact: Charles M White, PharmD    860-545-2221    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         
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Jeffrey Kluger, MD Hartford Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00282620     History of Changes
Other Study ID Numbers: KLUG001817HE
Study First Received: January 25, 2006
Last Updated: November 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Hartford Hospital:
Implantable Cardioverter Defibrillator
Magnesium
Electrocardiogram
Ventricular Arrhythmia

ClinicalTrials.gov processed this record on November 27, 2014