Status:
COMPLETED
Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease
Lead Sponsor:
University of Florida
Collaborating Sponsors:
American Heart Association
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 lifes...
Eligibility Criteria
Inclusion
- Current hypertension (blood pressure \> 140/90 mmHg) or current use of anti-hypertensive medications AND
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00379808
Start Date
July 1 2006
End Date
August 1 2009
Last Update
July 23 2012
Active Locations (1)
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1
University of Florida Family Practice Medical Group Clinic
Gainesville, Florida, United States, 32601