Trial record 9 of 17 for:    Open Studies | "Hyperlipoproteinemia Type II"

Evaluation of Chylomicrons Metabolism in Sub-Clinical Atherosclerosis in Patients Whit Heterozigous Familial Hypercholesterolemia (FH) Treated With Statin Plus Ezetimibe

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00475826
First received: May 18, 2007
Last updated: March 20, 2008
Last verified: May 2007
  Purpose

Study Title: Evaluation of chylomicrons metabolism in sub-clinical atherosclerosis in patients whit Heterozigous Familial Hypercholesterolemia (FH) treated with statin plus ezetimibe.

Background:

Coronary artery calcification (CAC) is a marker of sub-clinical coronary atherosclerosis which correlates with higher risk of clinical events. It was already demonstrated that CAC is more prevalent in patients with FH compared with normal individuals. A number of studies demonstrated that plasmatic removal of chylomicrons is defective in patients with atherosclerosis. Despite the fact that is still controversial whether this impairment occurs in patients with HF when compared to normal controls, the kinetics of chylomicrons has not been studied in HF patients with and without atherosclerosis and more important, it is not clear if those changes may be observed in the sub-clinical disease, as reported for CAC in asymptomatic individuals.

Previous studies have demonstrated the inverse correlation among LDL-C levels and the removal of remnants chylomicrons using artificial chylomicrons technique. It is also well known that high doses of more potent statins are more effective to remove chylomicrons from the plasma due to better expression of LDL-C receptors through plasma LDL-C reduction. It was not evaluated yet if the association of ezetimibe and statin, enhancing LDL-C receptors expression in the liver would enhance the efficacy of the monotherapy with statins to remove artificial chylomicrons in patients with HF.

Study design:

Open, randomized, single-blinded study in which twenty six outpatients from the Lipids Clinical Unit at the Heart Institute (INCOR), University of São Paulo, previously diagnosed with FH according to US MED PED criteria, without history of CD and a CAC evaluation by MSCT (Multiple Sensors Computed Tomography) in the previous year will be compared to 26 control individuals matched by age and sex collected from the database of the Lipids Metabolism Laboratory.

Patients will be randomized to receive simvastatin 40 mg as monotherapy or in combination with ezetimibe 10 mg and will undergoing three kinetics studies to demonstrate the effects of simvastatin 40 mg on the kinetics of the chylomicrons along with other laboratorial dosages ( lipid fractions, hepatic enzymes and CK).

The primary endpoint of this study is to evaluate if there is any correlation among the reduction of the plasma clearance of chylomicrons by the artificial chylomicrons technique and the presence of sub-clinical atherosclerosis; the secondary endpoint is to evaluate if ezetimibe/simvastatin enhances the effects of simvastatin alone in the removal of chylomicrons in patients with HF.


Condition Intervention
Heterozigous Familial Hypercholesterolemia
Drug: Statins and Ezetimibe

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Official Title: Evaluation of Chylomicrons Metabolism in Sub-Clinical Atherosclerosis in Patients Whit Heterozigous Familial Hypercholesterolemia (FH) Treated With Statin Plus Ezetimibe

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Evaluate if there is any correlation among the reduction of the plasma clearance of chylomicrons by the artificial chylomicrons technique and the presence of sub-clinical atherosclerosis [ Time Frame: Five months ]

Secondary Outcome Measures:
  • Evaluate if ezetimibe/simvastatin enhances the effects of simvastatin alone in the removal of chylomicrons in patients with HF. [ Time Frame: Five Months ]

Study Start Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heterozigous Familial Hypercholesterolemia patients
  • Age 18 to 70
  • Male and Female
  • Coronary artery calcification

Exclusion Criteria:

  • Coronary artery disease
  • Cerebrovascular disease
  • Diabetes Mellitus
  • Heart Failure Class III-IV
  • Thyroid disease
  • Peripheral Artery disease
  • Pregnancy, women without anticonceptive method
  • Kidney disease or calcium disturbs
  • Thoracic Cancer
  • Use of Beta Blockers, diuretics, glucocorticoids ,hormone replacement therapy except oral anticonception
  • Use of lipid lowering drugs for the last six weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475826

Contacts
Contact: Bruno Alcova Nogueira, MD (11)30695320 brunoalcova@yahoo.com.br

Locations
Brazil
Heart Institute Recruiting
Sao Paulo, SP, Brazil, 05403-900
Contact: Bruno Alcova Nogueira, MD    (11)30695320    brunoalcova@yahoo.com.br   
Principal Investigator: Bruno Alcova Nogueira, MD         
Sub-Investigator: Raul Dias Santos Filho, Phd         
Sponsors and Collaborators
University of Sao Paulo
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Bruno Alcova Nogueira, MD Heart Institute-Universaty Of Sao Paulo
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00475826     History of Changes
Other Study ID Numbers: 1067/06
Study First Received: May 18, 2007
Last Updated: March 20, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Heterozigous Familial Hypercholesterolemia
Sub-clinical atherosclerosis
Chylomicrons metabolism
Statin plus ezetimibe
Coronary artery calcification

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Atherosclerosis
Arteriosclerosis
Hypercholesterolemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014