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

Sponsor
University of Leipzig (Other)
Overall Status
Completed
CT.gov ID
NCT00298909
Collaborator
(none)
48
Enrollment
1
Location
3
Arms
39
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: physical exercise
  • Drug: niaspan (extended-release niacin)
  • Drug: niacin
  • Other: control
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

niacin

Drug: niaspan (extended-release niacin)
niaspan (extended-release niacin)

Drug: niacin
niacin extended-release
Active Comparator: 2

physical exercise

Behavioral: physical exercise
physical exercise
Placebo Comparator: 3

control

Other: control
control

Outcome Measures

Primary Outcome Measures

  1. relative effect on flow-mediated dilatation of radial artery [6 months]

Secondary Outcome Measures

  1. lipid profile [6 months]

  2. biochemical markers of atherosclerosis [6 months]

  3. expression of monocyte surface markers [6 months]

  4. oxidative stress [6 months]

  5. thrombogenicity [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Leipzig Heart Center Leipzig Germany 04289

Sponsors and Collaborators

  • University of Leipzig

Investigators

  • Principal Investigator: Steffen Desch, MD, Heart Center Leipzig - University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steffen Desch, MD, Priv.-Doz. Dr. med., University of Leipzig
ClinicalTrials.gov Identifier:
NCT00298909
Other Study ID Numbers:
  • Leipzig-02
First Posted:
Mar 3, 2006
Last Update Posted:
Jul 31, 2012
Last Verified:
Jul 1, 2012
Additional relevant MeSH terms:
Coronary Disease
Hypolipoproteinemias
Niacin
Niacinamide
Nicotinic Acids

Study Results

No Results Posted as of Jul 31, 2012