Exercise Versus Niacin in Patients With Coronary Artery Disease (CAD) and Low High-Density Lipoproteins (HDL)

Study Overview
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Brief Summary
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The investigators want to study the relative effects of physical exercise vs. extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and low HDL cholesterol (good cholesterol) on lipid profile endothelial function as measured by ultrasound The endothelium is the inner part of the blood vessels. Impaired endothelial function is known to be associated with atherosclerosis which can ultimately lead to diseases such as stroke, heart attack and others. Endothelial function can be assessed non-invasively by ultrasound. Both interventions mentioned above have been shown to have a beneficial effect on lipid profile and endothelial function. However, the relative effects are unclear.

Detailed Description
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Comparison of physical exercise vs. extended-release niacin in patients with CAD and low HDL cholesterol (< 1,03 mmol/L) on lipid profile and endothelial function as measured by flow-mediated dilatation of radial artery. Secondary goals are the assessment of biochemical markers of atherosclerosis, expression of monocyte surface markers, oxidative stress and thrombogenicity.

Official Title
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Exercise Versus Extended-Release Niacin in Patients With Coronary Heart Disease and Low High-Density Lipoproteins (HDL) Cholesterol: Effect on Lipid Profile and Endothelial Function

Conditions
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Coronary Disease, Hypolipoproteinemia

Intervention / Treatment
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* Behavioral: physical exercise
* Drug: niaspan (extended-release niacin)
* Drug: niacin
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary disease Low HDL cholesterol Age limits (see below) Exclusion Criteria: Unstable angina oder MI within 3 months prior to inclusion CAD with indication for bypass surgery Left main disease ( > 25% stenosis diameter) Ejection fraction < 40% Higher degree heart valve disease Higher degree ventricular arrhythmias Type 1 Diabetes Severe disorders of lipoprotein metabolism (Low-density lipoprotein cholesterol (LDL)> 5.0 mmol/L) Severe liver disease Thyroid disease Alcohol or drug abuse Pregnancy Stroke or Transient Ischemic Attack (TIA) within 3 months prior to inclusion Allergy against niacin oder other ingredient of niaspan Participation in other clinical trial within 30 days prior to inclusion Acute gastric ulcer Arterial bleeding Uncontrolled severe arterial hypertension Treatment with lipid-lowering drug other than Hydroxy-Methylglutaryl Coenzyme A (HMG-CoA)-inhibitor within 3 months prior to inclusion

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>niacin | Drug: niaspan (extended-release niacin)<br>* niaspan (extended-release niacin)<br>Drug: niacin<br>* niacin extended-release<br>|
| Active Comparator: 2<br>physical exercise | Behavioral: physical exercise<br>* physical exercise<br>|
| Placebo Comparator: 3<br>control | Other: control<br>* control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative effect on flow-mediated dilatation of radial artery |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile |  | 6 months | 
| biochemical markers of atherosclerosis |  | 6 months | 
| expression of monocyte surface markers |  | 6 months | 
| oxidative stress |  | 6 months | 
| thrombogenicity |  | 6 months |