High-Density Lipoprotein (HDL) Treatment Study

NCT00458055 | Completed DMC

• 1 other identifier: MUHC-RI 0906
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

A low level of plasma high-density lipoprotein (HDL) cholesterol, "the good cholesterol", is the most common lipid abnormality observed in patients with a premature atherosclerotic cardiovascular disease. HDL carry excess cholesterol from peripheral tissues to the liver to be metabolized or excreted, a process known as reverse cholesterol transport. Epidemiological studies have shown an inverse correlation between plasma levels of HDL cholesterol and the risk of cardiovascular disease. An increase in plasma HDL cholesterol levels by 1 mg/dL may reduce the risk of cardiovascular disease by 2 to 3%. The standard care of treatment for a low level of HDL cholesterol is: 1) lifestyle modifications including exercise, smoking cessation, weight control, moderate alcohol intake and decreased dietary fat intake - all patients are encouraged to follow these lifestyle modifications; 2) medications which can raise HDL cholesterol. Currently used medications to treat lipid disorders can increase, in some extent, HDL cholesterol. These include niacin (vitamin B3), fibric acid derivatives (fibrates) and statins. However there is no data on the effect of these medications on severe cases of HDL deficiency. This project aims to determine whether currently available medications, used in standard medical practice for the treatment of lipoprotein disorders, can substantially increase HDL cholesterol in severe cases of HDL deficiencies.

Conditions

Coronary Arteriosclerosis; Hypoalphalipoproteinemias; Genetic Diseases, Inborn

Keywords

Lipid lowering agents; Drug treatment; Statin; Fibrate; Niacin; Cellular cholesterol efflux

Outcome Measures

Primary Outcomes (1)

• HDL cholesterol

  9 months

Secondary Outcomes (1)

• apo AI

  9 months

Interventions

Atorvastatin; Fenofibrate; Niacin DRUG

Atorvastatin 20 mg; Fenofibrate 200 mg; Niacin 2g used sequentially for 8 weeks, after 4 weeks washout.

Also known as: Lipotor; Tricor; Niaspan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- HDL deficiency (HDL-cholesterol \< 5th percentile, age and gender-matched)

You may not qualify if:

• Triglycerides ≥ 5 mmol/L
• Diabetes
• Severe obesity (BMI ≥ 30)
• Alcohol intake \> 21 drinks/week
• Untreated disease (thyroid, hepatic or renal)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

MUHC-Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (6)

• McPherson R, Frohlich J, Fodor G, Genest J, Canadian Cardiovascular Society. Canadian Cardiovascular Society position statement--recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease. Can J Cardiol. 2006 Sep;22(11):913-27. doi: 10.1016/s0828-282x(06)70310-5.

  PMID: 16971976 BACKGROUND

• Brewer HB Jr. High-density lipoproteins: a new potential therapeutic target for the prevention of cardiovascular disease. Arterioscler Thromb Vasc Biol. 2004 Mar;24(3):387-91. doi: 10.1161/01.ATV.0000121505.88326.d2. No abstract available.

  PMID: 15003970 BACKGROUND

• Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. N Engl J Med. 1999 Aug 5;341(6):410-8. doi: 10.1056/NEJM199908053410604.

  PMID: 10438259 BACKGROUND

• Schaefer JR, Schweer H, Ikewaki K, Stracke H, Seyberth HJ, Kaffarnik H, Maisch B, Steinmetz A. Metabolic basis of high density lipoproteins and apolipoprotein A-I increase by HMG-CoA reductase inhibition in healthy subjects and a patient with coronary artery disease. Atherosclerosis. 1999 May;144(1):177-84. doi: 10.1016/s0021-9150(99)00053-2.

  PMID: 10381291 BACKGROUND

• Ashen MD, Blumenthal RS. Clinical practice. Low HDL cholesterol levels. N Engl J Med. 2005 Sep 22;353(12):1252-60. doi: 10.1056/NEJMcp044370. No abstract available.

  PMID: 16177251 BACKGROUND

• Schaefer EJ, Asztalos BF. The effects of statins on high-density lipoproteins. Curr Atheroscler Rep. 2006 Jan;8(1):41-9. doi: 10.1007/s11883-006-0063-3.

  PMID: 16455013 BACKGROUND

Related Links

• Cholesterol and your heart
• Treatment of high cholesterol

MeSH Terms

Conditions

Coronary Artery Disease; Hypoalphalipoproteinemias; Genetic Diseases, Inborn

Interventions

Atorvastatin; Fenofibrate; Niacin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Jacques Genest, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 9, 2007
• Study Start: November 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 4, 2008

Record last verified: 2008-06

Locations

CA (1)