Coronary Artery Disease, Diabetes, Dyslipidemia, Hypertension
Conditions
Keywords
Hemodynamics, Hypertension, Dyslipidemia, Diabetes, Implantable Cardioverter Defibrillator, Blood Pressure
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.
Interventions
Sponsors
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed