Effects of Miconazole on Blood Flow

NCT00004575 | Completed Phase 1

• 2 other identifiers: 00007700-H-0077
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effect of the drug miconazole on blood vessel dilation. Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is produced by the cells that line blood vessels. Normal volunteers between the ages of 21 to 60 may participate in this study. Candidates will be screened for eligibility with a medical history, physical examination, electrocardiogram and routine laboratory tests. Those enrolled will be injected with miconazole to study its effects on blood vessels. Study participants will take three aspirin tablets. After administration of a local anesthetic, small tubes will be inserted through a needle into the artery and vein of the forearm. These will be used to measure blood pressure and to draw blood samples during the study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood will flow into the arm, stretching the strain gauge, and the flow measurement will be recorded. Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be given through the arterial catheter. Bradykinin stimulates the release of EDHF and can lower blood pressure. Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure and heart failure. Miconazole is commonly prescribed to treat various infections, including vaginal yeast infections, jock itch and athlete's foot. In much higher doses, it is used to treat fungal infections that have spread to the lungs, brain, kidneys, or bladder. LNMMA inhibits production of nitric oxide, another substance produced by the lining cells of blood vessels. Blood flow will be measured throughout the study, which will last approximately 3 hours.

Conditions

Healthy

Keywords

Endothelium; Vasodilation; Vascular Biology; Venous Occlusion Plethysmography

Interventions

Miconazole, L-NMMA, Bradykinin DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Healthy male or female volunteers (age 21-60 years). No presence of intercurrent illness. No current smoking (within previous 5 years). No hypertension (greater than 140/90). No diabetes. No hypercholesterolemia (total cholesterol greater than 240 mg/dl). No pregnancy or menopause. No renal failure (creatinine greater than 1.4 mg/dl). No allergies to miconazole, parabens, castor oil or aspirin. No bleeding disorders. No consumption of any medications during the last one week, including vitamins and unconventional medications.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Feletou M, Vanhoutte PM. Endothelium-derived hyperpolarizing factor. Clin Exp Pharmacol Physiol. 1996 Dec;23(12):1082-90. doi: 10.1111/j.1440-1681.1996.tb01174.x.

  PMID: 8977164 BACKGROUND

• Furchgott RF, Vanhoutte PM. Endothelium-derived relaxing and contracting factors. FASEB J. 1989 Jul;3(9):2007-18.

  PMID: 2545495 BACKGROUND

• Keef KD, Bowen SM. Effect of ACh on electrical and mechanical activity in guinea pig coronary arteries. Am J Physiol. 1989 Oct;257(4 Pt 2):H1096-103. doi: 10.1152/ajpheart.1989.257.4.H1096.

  PMID: 2801972 BACKGROUND

MeSH Terms

Conditions

Aneurysm

Interventions

Miconazole; omega-N-Methylarginine; Bradykinin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arginine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Kinins; Intercellular Signaling Peptides and Proteins; Peptides; Neuropeptides; Oligopeptides; Proteins; Nerve Tissue Proteins; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 17, 2000
• First Posted: May 22, 2002
• Study Start: February 1, 2000
• Study Completion: October 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2001-10

Locations

US (1)