Investigation of Miconazole as an Inhibitor of Endothelium-Derived Hyperpolarizing Factor
Miconazole, L-NMMA, Bradykinin
Cardiovascular Diseases
+ Vascular Diseases
+ Aneurysm
Treatment Study
Summary
Study start date: February 1, 2000
Actual date on which the first participant was enrolled.The vascular endothelium synthesizes at least three potent vasodilator substances: nitric oxide (NO), prostacyclin and an endothelium-derived hyperpolarizing factor (EDHF). EDHF release is stimulated by receptor-dependent agonists such as acetylcholine and bradykinin (BK), and leads to hyperpolarization of the underlying smooth muscle cells presumably by opening Ca(2+)-activated K(+) channels. Indirect pharmacologic evidence suggests that EDHF is a cytochrome P450-derived arachidonic acid metabolite, presumably an epoxide. Numerous inhibitors of EDHF have been defined in animal tissues. Of these, miconazole has proven to be safe when administered to humans as a topical and parenteral antifungal agent. At levels that are attained with routine clinical use, it has a rapid onset of action with high specificity of inhibition of EDHF in animal models. This study is designed to investigate the safety and efficacy of intra-arterial miconazole in inhibiting BK-mediated forearm vasodilation in normal volunteers.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps