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The Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control

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ClinicalTrials.gov Identifier: NCT00282659
Recruitment Status : Unknown
Verified March 2007 by Hartford Hospital.
Recruitment status was:  Recruiting
First Posted : January 27, 2006
Last Update Posted : November 5, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine if magnesium can improve blood pressure, cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators (ICDs).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Hypertension Dyslipidemia Diabetes Drug: magnesium L-lactate Phase 4

Detailed Description:

Magnesium is the second most abundant intracellular cation and plays a vital role in many physiologic processes. It has been determined that patients with cardiovascular disease have intracellular magnesium (Mgi) deficiencies. Among the ICD registries in Europe and the United States 64% and 77% of patients also carry the diagnosis of CAD, respectively. Patients with CAD have risk factors that lead to the development and or propagation of atherosclerosis. Paramount among these risk factors are hypertension, dyslipidemia, and diabetes.

Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the effect they have on cholesterol, blood pressure, and blood glucose.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Use of Magnesium to Improve Hemodynamics, Cholesterol, and Glucose Control: A Substudy of AdMag
Study Start Date : January 2006
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Blood pressure, cardiac output, systemic vascular resistance, thoracic fluid content, total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, and blood glucose [ Time Frame: at baseline, 3, and 6 months of follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • Creatinine clearance less than 30mL/min
  • Lactic acidosis or systemic acidosis syndrome
  • Previous intolerance to magnesium L-lactate
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282659


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

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102-5037
Contact: Charles M White, PharmD    860-545-2221    Cmwhite@harthosp.org   
Contact: Jeffrey Kluger, MD    860-545-2883    Jkluger@harthosp.org   
Principal Investigator: Charles M White, PharmD         
Sub-Investigator: Jeffrey Kluger, MD         
Sub-Investigator: Nickole N Henyan, PharmD         
Sub-Investigator: Stephen D Sander, PharmD         
Sub-Investigator: Effie L Gillespie, PharmD         
Sub-Investigator: Christopher A Clyne, MD         
Sub-Investigator: Craig I Coleman, PharmD         
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Charles M White, PharmD University of Connecticut School of Pharmacy, Hartford Hospital Division of Drug Information
More Information

ClinicalTrials.gov Identifier: NCT00282659     History of Changes
Other Study ID Numbers: WHIT001799HI
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: November 5, 2007
Last Verified: March 2007

Keywords provided by Hartford Hospital:
Hemodynamics
Hypertension
Dyslipidemia
Diabetes
Implantable Cardioverter Defibrillator
Blood Pressure

Additional relevant MeSH terms:
Hypertension
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Lipid Metabolism Disorders
Metabolic Diseases