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Study of the Response of Human Small Blood Vessels

Primary Purpose

Healthy, Hypercholesterolemia, Hypertension

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
investigate the relationship between in vivo and in vitro vascular responses
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Endothelium, Hypercholesterolemia, Hypertension, Microvessels, Vasodilation, Normal Volunteer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Patients (men and nonpregnant women) with systemic hypertension, patients with hypercholesterolemia, and normal volunteers. All blood pressure recordings must be consistently elevated. No renovascular hypertension or other etiologies for elevated blood pressure. No definite evidence of accelerated or malignant hypertension (diastolic pressures above 115 mmHg, with associated encephalopathic changes, papilledema, progressive renal failure, or congestive heart failure), or serious intercurrent illness. Patients in whom withdrawal of antihypertensive medications is considered hazardous are ineligible. Patients in whom the blood pressure remains at normal levels 2 weeks after withdrawal of antihypertensive treatment will be closely monitored until they become hypertensive, at which time they will undergo the study. Patients in whom blood pressure does not increase after 2 months of discontinuation of therapy will be excluded from the study. Patients with coexistent hypertension and hypercholesterolemia are ineligible. Normal volunteers who are not taking any kind of medication are eligible. No history of diabetes, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon. No history of keloid formation. All patients must be capable of giving informed consent for all procedures.

Sites / Locations

  • National Heart, Lung and Blood Institute (NHLBI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001622
Brief Title
Study of the Response of Human Small Blood Vessels
Official Title
Study of the Relation Between In Vivo and In Vitro Response of Human Small Vessels
Study Type
Interventional

2. Study Status

Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

Brief Summary
A layer of cells called the endothelium line the walls of blood vessels. These cells produce substances that control the tone of blood vessels and thus control blood flow through the vessel. One of the substances produced involved in the control of blood vessel function is nitric oxide. Nitric oxide (NO) plays a role in the relaxation of blood vessels. Researchers have been interested in the function of the endothelium in patients with high blood pressure (essential hypertension) and patients with high cholesterol (hypercholesterolemia). After conducting studies on the endothelium and nitric oxide, researchers have found that the endothelium is indeed functioning abnormally in patients with high blood pressure and high cholesterol. In addition, researchers have determined that the dysfunction is a result of abnormalities in the nitric oxide (NO) system. In this study researchers plan to investigate the relationship between blood vessel responses in real-life settings versus laboratory settings in normal volunteers, patients with high blood pressure, and patients with high cholesterol.
Detailed Description
Over the last ten years, we have been interested in the investigation of endothelial function in patients with essential hypertension and patients with hypercholesterolemia. We have performed intra-arterial infusion of endothelium-dependent and endothelium-independent drugs into the brachial artery with noninvasive measurement of the response of the forearm vasculature by means of strain gauge plethysmography. Those studies have allowed us to: a) demonstrate the presence of endothelial dysfunction in patients with essential hypertension and in patients with hypercholesterolemia; and b) identify an abnormality in the endothelium-derived nitric oxide system that is responsible for endothelial dysfunction in these patients. Further studies to more precisely determine the intracellular processes that mediate this abnormality in endothelial function in these patients are limited by the inherent shortcomings of the in vivo technique. An alternative possibility is the study of human small vessels in vitro; however, the relationship between in vivo and in vitro vascular responses to endothelium-dependent and -independent agonists has not been established. In the present study, we propose to investigate this relationship in normal volunteers, patients with essential hypertension, and patients with hypercholesterolemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Hypercholesterolemia, Hypertension
Keywords
Endothelium, Hypercholesterolemia, Hypertension, Microvessels, Vasodilation, Normal Volunteer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
87 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
investigate the relationship between in vivo and in vitro vascular responses

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patients (men and nonpregnant women) with systemic hypertension, patients with hypercholesterolemia, and normal volunteers. All blood pressure recordings must be consistently elevated. No renovascular hypertension or other etiologies for elevated blood pressure. No definite evidence of accelerated or malignant hypertension (diastolic pressures above 115 mmHg, with associated encephalopathic changes, papilledema, progressive renal failure, or congestive heart failure), or serious intercurrent illness. Patients in whom withdrawal of antihypertensive medications is considered hazardous are ineligible. Patients in whom the blood pressure remains at normal levels 2 weeks after withdrawal of antihypertensive treatment will be closely monitored until they become hypertensive, at which time they will undergo the study. Patients in whom blood pressure does not increase after 2 months of discontinuation of therapy will be excluded from the study. Patients with coexistent hypertension and hypercholesterolemia are ineligible. Normal volunteers who are not taking any kind of medication are eligible. No history of diabetes, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon. No history of keloid formation. All patients must be capable of giving informed consent for all procedures.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6313250
Citation
Furchgott RF. Role of endothelium in responses of vascular smooth muscle. Circ Res. 1983 Nov;53(5):557-73. doi: 10.1161/01.res.53.5.557. No abstract available.
Results Reference
background
PubMed Identifier
8021003
Citation
Falloon BJ, Heagerty AM. In vitro perfusion studies of human resistance artery function in essential hypertension. Hypertension. 1994 Jul;24(1):16-23. doi: 10.1161/01.hyp.24.1.16.
Results Reference
background
PubMed Identifier
7796498
Citation
Goode GK, Heagerty AM. In vitro responses of human peripheral small arteries in hypercholesterolemia and effects of therapy. Circulation. 1995 Jun 15;91(12):2898-903. doi: 10.1161/01.cir.91.12.2898.
Results Reference
background

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Study of the Response of Human Small Blood Vessels

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