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

Phase 4

Completed

• Conditions: Coronary Disease; Hypolipoproteinemia
• Interventions: Other: control; Behavioral: physical exercise; Drug: niaspan (extended-release niacin); Drug: niacin

• Registration Number: NCT00298909
• Lead Sponsor: University of Leipzig

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-02
• Study First Posted: 2006-03-03
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-29
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	control	control
1	niacin	niacin
2	physical exercise	physical exercise
1	niaspan (extended-release niacin)	niacin

Primary Outcome Measures

Name	Time	Method
relative effect on flow-mediated dilatation of radial artery	6 months

Secondary Outcome Measures

Name	Time	Method
lipid profile	6 months
biochemical markers of atherosclerosis	6 months
expression of monocyte surface markers	6 months
oxidative stress	6 months
thrombogenicity	6 months

Trial Locations

Locations (1)

University of Leipzig Heart Center; 🇩🇪 Leipzig, Germany