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Endothelial Hyperpolarization in Humans

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperlipidemia

Intervention: Tetraethylammonium (TEA) (Drug); L-NG-monomethyl Arginine (L-NMMA) (Drug); Bradykinin (Drug); Sodium nitroprusside (Drug); Acetylcholine (Drug); Saline (Drug); Fluconazole (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Arshed A Quyyumi, MD, Principal Investigator, Affiliation: Emory University School of Medicine, Division of Cardiology

Summary

The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor (EDHF) plays in dilating blood vessels and whether it differs between healthy people and those with high cholesterol. A second purpose of the study is to determine the identity of EDHF.

Clinical Details

Official title: Physiology and Pathologic Role of Endothelium-Derived Hyperpolarizing Factor in Humans

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome:

Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration

Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA)

Secondary outcome:

Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA)

Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration

Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration

Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration

Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration

Change in Tissue Plasminogen Activator (t-PA) Release

Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration

Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration

Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole, Tetraethylammonium (TEA), and Bradykinin Administration

Detailed description: The vascular endothelium synthesizes at least four potent vasodilator substances: nitric oxide (NO), prostacyclin, carbon monoxide and endothelium-derived hyperpolarizing factor (EDHF) that contribute to vasodilator tone, and to inhibition of platelet activation and inflammation. 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 Ca2+-activated K+ channels. Indirect pharmacological evidence suggests that EDHF is a cytochrome P450-derived arachidonic acid metabolite, presumably an epoxide. Although the pivotal role of NO to conduit vessel dilation in response to acute increases in shear stress is well known, its' contribution to dilation with sustained increases in flow are minimal, and may be due to EDHF release.

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Hyperlipidemic (LDL > 140)

- Healthy Volunteer

Exclusion Criteria:

- Pregnancy

- Diabetes mellitus

- Cardiovascular Disease

- Hypertension

- Use of any regular medications

- Renal insufficiency

- Smoking (current or within the past 5 years)

- Bleeding disorder

Locations and Contacts

Emory University School of Medicine, Atlanta, Georgia 30322, United States
Additional Information

Starting date: July 2002
Last updated: May 12, 2015

Page last updated: August 23, 2015

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