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NCT00282659 Clinical Trial

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

Hypertension Clinical Trial

Official title:
The Use of Magnesium to Improve Hemodynamics, Cholesterol, and Glucose Control: A Substudy of AdMag

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00282659
Other study ID # WHIT001799HI
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2006
Est. completion date June 2008

Study information
Verified date May 2019
Source Hartford Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• magnesium L-lactate

Locations
Country Name City State
United States Hartford Hospital Hartford Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure, cardiac output, systemic vascular resistance, thoracic fluid content, total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, and blood glucose at baseline, 3, and 6 months of follow-up
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