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

Coronary Heart Disease Clinical Trial

Official title:

Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379808
• Other study ID #: 06011312
• Secondary ID: AHA0615253B
• Status: Completed
• Phase: N/A
• First received: September 20, 2006
• Last updated: June 7, 2012
• Start date: July 2006
• Est. completion date: August 2009

Study information

• Verified date: June 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• montelukast
10 mg tablet (masked by capsule) daily for 1 month
• Placebo
1 lactose-containing capsule daily for 1 month

Locations

Country	Name	City	State
United States	University of Florida Family Practice Medical Group Clinic	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High-sensitivity C-reactive Protein	measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)	1 month	No
Secondary	High Density Lipoprotein (HDL)-Cholesterol	Lipid levels were determined at a clinical laboratory (Quest Diagnostics)	1 month	No