Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease - Full Text View

Sponsor:	University of Florida
Collaborator:	American Heart Association
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00379808

Purpose

The purpose of this study is to determine whether a particular substance involved in inflammation, called leukotrienes, is involved in causing heart disease to occur or to progress.

Condition	Intervention
Coronary Heart Disease	Drug: montelukast Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

high-sensitivity C-reactive protein [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Lipid levels (triglycerides, total cholesterol, HDL-C) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intercellular Adhesion Molecule [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Monocyte Chemotactic Protein 1 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
TNF-alpha [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Vascular Cell Adhesion Molecule [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Serum Amyloid A [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Lipoprotein Lipase A2 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Various Interleukins [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 1 lactose-containing capsule daily for 1 month	Drug: Placebo 1 lactose-containing capsule daily for 1 month
2: Active Comparator 1 montelukast 10 mg tablet (masked by capsule) daily for 1 month	Drug: montelukast 10 mg tablet (masked by capsule) daily for 1 month

Detailed Description:

The focus of this study is to better understand why some adults develop heart disease and others do not. There are many known factors which play a role in causing heart disease, such as diet and lifestyle. Also, we know that inflammation, a process in the body which causes painful joints in arthritis or swelling at a site if injury, also contributes to heart disease. In particular, we will address whether leukotrienes, a component of inflammation, is involved in promoting heart disease. We will study this by giving subjects at high risk for heart disease a drug called montelukast which causes leukotrienes to have a reduced effect in the body. In addition for comparison, we will give other subjects a placebo for the same amount of time. These subjects will then be crossed-over and will receive either montelukast or placebo depending on which treatment they received first. We will compare these subjects using blood tests to see if subjects who take montelukast show signs of less inflammation caused by early heart disease as compared to subjects who do not.

Eligibility

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

Criteria

Inclusion Criteria:

-Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND

Exclusion Criteria:

Current use of lipid-lowering medications
Current use of montelukast
Poorly controlled hypertension, where systolic blood pressure is greater than 160 or diastolic blood pressure is greater than 100
Use of steroid drugs, non-steroidal anti-inflammatory drugs or other anti-inflammatory medications in the two weeks prior to enrollment. (low dose aspirin ( < 325 mg) is OK, but indication must be cardiovascular)
Current recreational drug use
Other cardiovascular disease or previous cardiovascular event. These include:
history of angina pectoris
history of heart failure
presence of a cardiac pacemaker
history of myocardial infarction
previous revascularization procedure
history cerebrovascular disease including stroke and transient ischemic attack
Pregnancy or lactation
Diabetes mellitus
Lactose intolerance
Contraindications to montelukast therapy
Alcoholism
Known hepatic disease
Existing chronic obstructive pulmonary disease, asthma, allergic rhinitis
Active chronic immune, infectious, neoplastic or inflammatory diseases requiring therapy (such as active Hepatitis B, Hepatitis C, HIV)
Immunosuppressant therapy or known immunosuppression due to disease HDL < 40 mg/dL (although this would be a risk factor for heart disease, because of preliminary data which indicates that montelukast may lower HDL levels, we will exclude patients with abnormally low HDL from study)
Other criteria at investigator discretion that are deemed to make the subject a poor candidate for the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379808

Contacts

Contact: Anzeela M Schentrup, PharmD	(352) 273-6326	anzee@ufl.edu
Contact: Julie A Johnson, PharmD	(352) 273-6007	johnson@cop.ufl.edu

Locations

United States, Florida
University of Florida Family Practice Medical Group Clinic	Recruiting
Gainesville, Florida, United States, 32601
Principal Investigator: Julie A Johnson, PharmD
Sub-Investigator: Karen Hall, MD
Sub-Investigator: Anzeela M Schentrup, MS, PharmD

Sponsors and Collaborators

University of Florida

American Heart Association

Investigators

Principal Investigator:

Julie A Johnson, PharmD

University of Florida

More Information

No publications provided

Responsible Party:	University of Florida ( Julie A. Johnson )
Study ID Numbers:	06011312, AHA0615253B
Study First Received:	September 20, 2006
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00379808 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

coronary heart disease
montelukast
inflammation

Additional relevant MeSH terms:

Coronary Artery Disease
Coronary Disease
Heart Diseases
Montelukast
Arterial Occlusive Diseases
Respiratory System Agents
Myocardial Ischemia
Hormone Antagonists
Physiological Effects of Drugs

Vascular Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Arteriosclerosis
Pharmacologic Actions
Leukotriene Antagonists
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010