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

NCT ID: NCT00379808

Last Updated: 2012-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-08-31

Brief Summary

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.

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

1 lactose-containing capsule daily for 1 month

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 lactose-containing capsule daily for 1 month

Montelukast 10 mg

1 montelukast 10 mg tablet (masked by capsule) daily for 1 month

Group Type: ACTIVE_COMPARATOR

montelukast

Intervention Type: DRUG

10 mg tablet (masked by capsule) daily for 1 month

Interventions

montelukast

10 mg tablet (masked by capsule) daily for 1 month

Intervention Type: DRUG

Placebo

1 lactose-containing capsule daily for 1 month

Intervention Type: DRUG

Other Intervention Names

Singulair

Eligibility 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, human immunodeficiency virus (HIV))
• Immunosuppressant therapy or known immunosuppression due to disease high density lipoprotein (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie A Johnson, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Family Practice Medical Group Clinic

Gainesville, Florida, United States

Countries

United States

Other Identifiers

AHA0615253B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

06011312

Identifier Type: -

Identifier Source: org_study_id