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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
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | niacin |
|
| 2 | Active Comparator | physical exercise |
|
| 3 | Placebo Comparator | control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical exercise | Behavioral | physical exercise |
| |
| niaspan (extended-release niacin) |
| Measure | Description | Time Frame |
|---|---|---|
| relative effect on flow-mediated dilatation of radial artery | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| lipid profile | 6 months | |
| biochemical markers of atherosclerosis | 6 months | |
| expression of monocyte surface markers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steffen Desch, MD | Heart Center Leipzig - University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leipzig Heart Center | Leipzig | 04289 | Germany |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D007009 | Hypolipoproteinemias |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D009525 | Niacin |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Drug |
niaspan (extended-release niacin) |
|
| niacin | Drug | niacin extended-release |
|
| control | Other | control |
|
| 6 months |
| oxidative stress | 6 months |
| thrombogenicity | 6 months |
| D008052 |
| Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |