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NCT Number: NCT00298909

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

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Heart Diseases Hypolipoproteinemia Hypolipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Leipzig Heart Center

Leipzig, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Physical exercise

Behavioral

physical exercise

niaspan (extended-release niacin)

Drug

niaspan (extended-release niacin)

niacin

Drug

niacin extended-release

Control

Other

control

Primary outcomes

  1. relative effect on flow-mediated dilatation of radial artery

    Time frame: 6 months

Secondary outcomes

  1. lipid profile

    Time frame: 6 months

  2. biochemical markers of atherosclerosis

    Time frame: 6 months

  3. expression of monocyte surface markers

    Time frame: 6 months

  4. oxidative stress

    Time frame: 6 months

  5. thrombogenicity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Mar 3, 2006
Registry last updated
Jul 31, 2012

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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