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High-Density Lipoprotein (HDL) Treatment Study
This study has been completed.
First Received: April 5, 2007   Last Updated: June 2, 2008   History of Changes
Sponsor: McGill University Health Center
Information provided by: McGill University Health Center
ClinicalTrials.gov Identifier: NCT00458055
  Purpose

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.


Condition Intervention
Coronary Arteriosclerosis
Hypoalphalipoproteinemias
Genetic Diseases, Inborn
Drug: Atorvastatin; Fenofibrate; Niacin

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Treatment Study for Severe High-Density Lipoprotein Deficiency

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • HDL cholesterol [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • apo AI [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: November 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Atorvastatin; Fenofibrate; Niacin
    Atorvastatin 20 mg; Fenofibrate 200 mg; Niacin 2g used sequentially for 8 weeks, after 4 weeks washout.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Triglycerides ≥ 5 mmol/L
  • Diabetes
  • Severe obesity (BMI ≥ 30)
  • Alcohol intake > 21 drinks/week
  • Untreated disease (thyroid, hepatic or renal)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458055

Locations
Canada, Quebec
MUHC-Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Jacques Genest, MD McGill University Health Center
  More Information

Additional Information:
Publications:
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. Erratum in: Can J Cardiol. 2006 Oct;22(12):1077.
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. No abstract available.
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.
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.
Ashen MD, Blumenthal RS. Clinical practice. Low HDL cholesterol levels. N Engl J Med. 2005 Sep 22;353(12):1252-60. Review. No abstract available. Erratum in: N Engl J Med. 2006 Jan 12;354(2):215.
Schaefer EJ, Asztalos BF. The effects of statins on high-density lipoproteins. Curr Atheroscler Rep. 2006 Jan;8(1):41-9. Review.

Responsible Party: McGill University Hospital Center ( Jacques Genest MD )
Study ID Numbers: MUHC-RI 0906
Study First Received: April 5, 2007
Last Updated: June 2, 2008
ClinicalTrials.gov Identifier: NCT00458055     History of Changes
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Lipid lowering agents
Drug treatment
Statin
Fibrate
Niacin
Cellular cholesterol efflux

Additional relevant MeSH terms:
Lipid Metabolism, Inborn Errors
Antimetabolites
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Hypolipoproteinemias
Arteriosclerosis
Hypoalphalipoproteinemias
Metabolism, Inborn Errors
Vitamins
Therapeutic Uses
Cardiovascular Diseases
Micronutrients
Dyslipidemias
Arterial Occlusive Diseases
Vitamin B Complex
Heart Diseases
Metabolic Diseases
Growth Substances
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Procetofen
Pharmacologic Actions
Coronary Disease
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 08, 2010