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

Primary Purpose

Coronary Disease, Hypolipoproteinemia

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
physical exercise
niaspan (extended-release niacin)
niacin
control
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Leipzig Heart Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

niacin

physical exercise

control

Outcomes

Primary Outcome Measures

relative effect on flow-mediated dilatation of radial artery

Secondary Outcome Measures

lipid profile
biochemical markers of atherosclerosis
expression of monocyte surface markers
oxidative stress
thrombogenicity

Full Information

First Posted
March 2, 2006
Last Updated
July 29, 2012
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT00298909
Brief Title
Exercise Versus Niacin in Patients With Coronary Artery Disease (CAD) and Low High-Density Lipoproteins (HDL)
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Hypolipoproteinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
niacin
Arm Title
2
Arm Type
Active Comparator
Arm Description
physical exercise
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
control
Intervention Type
Behavioral
Intervention Name(s)
physical exercise
Intervention Description
physical exercise
Intervention Type
Drug
Intervention Name(s)
niaspan (extended-release niacin)
Intervention Description
niaspan (extended-release niacin)
Intervention Type
Drug
Intervention Name(s)
niacin
Intervention Description
niacin extended-release
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
control
Primary Outcome Measure Information:
Title
relative effect on flow-mediated dilatation of radial artery
Time Frame
6 months
Secondary Outcome Measure Information:
Title
lipid profile
Time Frame
6 months
Title
biochemical markers of atherosclerosis
Time Frame
6 months
Title
expression of monocyte surface markers
Time Frame
6 months
Title
oxidative stress
Time Frame
6 months
Title
thrombogenicity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Desch, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

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

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