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Completed

NCT Number: NCT00282659

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

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).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Diabetes Diabetes Mellitus Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hypertension Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

magnesium L-lactate

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 27, 2006
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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