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

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:
Collaborator:
Hartford Hospital(HH) Research Endowment Funds
Information provided by:
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00282659
First received: January 25, 2006
Last updated: November 2, 2007
Last verified: March 2007
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
Hypertension
Dyslipidemia
Diabetes
 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 Use of Magnesium to Improve Hemodynamics, Cholesterol, and Glucose Control: A Substudy of AdMag

Resource links provided by NLM:

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

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: January 2006
Estimated Study Completion Date: June 2008
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.

  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
  • Creatinine clearance less than 30mL/min
  • Lactic acidosis or systemic acidosis syndrome
  • Previous intolerance to magnesium L-lactate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Hartford Hospital(HH) Research Endowment Funds
Investigators
Principal Investigator: Charles M White, PharmD University of Connecticut School of Pharmacy, Hartford Hospital Division of Drug Information
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00282659     History of Changes
Other Study ID Numbers: WHIT001799HI
Study First Received: January 25, 2006
Last Updated: November 2, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013