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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298909
First Posted: March 3, 2006
Last Update Posted: July 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steffen Desch, MD, University of Leipzig
  Purpose

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 Intervention Phase
Coronary Disease Hypolipoproteinemia Behavioral: physical exercise Drug: niaspan (extended-release niacin) Drug: niacin Other: control Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Steffen Desch, MD, University of Leipzig:

Primary Outcome Measures:
  • relative effect on flow-mediated dilatation of radial artery [ Time Frame: 6 months ]

Secondary Outcome 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 ]

Enrollment: 48
Study Start Date: March 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298909


Locations
Germany
University of Leipzig Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Steffen Desch, MD Heartcenter Leipzig GmbH
  More Information

Responsible Party: Steffen Desch, MD, Priv.-Doz. Dr. med., University of Leipzig
ClinicalTrials.gov Identifier: NCT00298909     History of Changes
Other Study ID Numbers: Leipzig-02
First Submitted: March 2, 2006
First Posted: March 3, 2006
Last Update Posted: July 31, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Hypolipoproteinemias
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs