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

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00379808
First received: September 20, 2006
Last updated: June 7, 2012
Last verified: June 2012
  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: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease

Resource links provided by NLM:


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 ]
    measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)


Secondary Outcome Measures:
  • High Density Lipoprotein (HDL)-Cholesterol [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Lipid levels were determined at a clinical laboratory (Quest Diagnostics)


Enrollment: 22
Study Start Date: July 2006
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
1 lactose-containing capsule daily for 1 month
Drug: Placebo
1 lactose-containing capsule daily for 1 month
Active Comparator: Montelukast 10 mg
1 montelukast 10 mg tablet (masked by capsule) daily for 1 month
Drug: montelukast
10 mg tablet (masked by capsule) daily for 1 month
Other Name: Singulair

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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
University of Florida Family Practice Medical Group Clinic
Gainesville, Florida, United States, 32601
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
ClinicalTrials.gov Identifier: NCT00379808     History of Changes
Other Study ID Numbers: 06011312, AHA0615253B
Study First Received: September 20, 2006
Results First Received: February 14, 2012
Last Updated: June 7, 2012
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014