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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: American Heart Association
• Treatments: Montelukast

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