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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2009

Detailed Description

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.

Interventions

  • Behavioral: physical exercise
    • physical exercise
  • Drug: niaspan (extended-release niacin)
    • niaspan (extended-release niacin)
  • Drug: niacin
    • niacin extended-release
  • Other: control
    • control

Arms, Groups and Cohorts

  • Experimental: 1
    • niacin
  • Active Comparator: 2
    • physical exercise
  • Placebo Comparator: 3
    • control

Clinical Trial Outcome Measures

Primary Measures

  • relative effect on flow-mediated dilatation of radial artery
    • Time Frame: 6 months

Secondary Measures

  • lipid profile
    • Time Frame: 6 months
  • biochemical markers of atherosclerosis
    • Time Frame: 6 months
  • expression of monocyte surface markers
    • Time Frame: 6 months
  • oxidative stress
    • Time Frame: 6 months
  • thrombogenicity
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Leipzig
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steffen Desch, MD, Priv.-Doz. Dr. med. – University of Leipzig
  • Overall Official(s)
    • Steffen Desch, MD, Principal Investigator, Heart Center Leipzig – University Hospital

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