Back to resultsThe Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control
Primary Purpose
Coronary Artery Disease, Hypertension, Dyslipidemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
magnesium L-lactate
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Hemodynamics, Hypertension, Dyslipidemia, Diabetes, Implantable Cardioverter Defibrillator, Blood Pressure
Eligibility 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
Sites / Locations
- Hartford Hospital
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00282659
Brief Title
The Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control
Official Title
The Use of Magnesium to Improve Hemodynamics, Cholesterol, and Glucose Control: A Substudy of AdMag
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
4. Oversight
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Hypertension, Dyslipidemia, Diabetes
Keywords
Hemodynamics, Hypertension, Dyslipidemia, Diabetes, Implantable Cardioverter Defibrillator, Blood Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
magnesium L-lactate
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles M White, PharmD
Organizational Affiliation
University of Connecticut School of Pharmacy, Hartford Hospital Division of Drug Information
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control
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