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Vasoreactivity in Carriers of Genetic Polymorphisms

NCT ID: NCT00160888

Last Updated: 2005-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

Study Completion Date

2006-12-31

Brief Summary

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The objective of the study is to assess the impact of genetic variation (especially polymorphisms of the gene coding endothelial nitric oxide synthase (eNOS) and the bradykinin B2 receptor gene) on venous and arterial responsiveness to vasodilators in healthy individuals without cardiovascular risk factors.

Detailed Description

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Study I: Using the dorsal hand vein compliance technique dose-response curves to bradykinin and sodium nitroprusside will be obtained in healthy volunteers during preconstriction with phenylephrine and after pretreatment with a single dose of 500 mg i.v. acetylsalicylic acid.

Study II: Using venous occlusion plethysmography dose-response curves to acetylcholine, sodium nitroprusside and L-NG-monomethyl-arginine (L-NMMA) will be obtained in healthy volunteers pretreated with a single dose of 500mg i.v. acetylsalicylic acid.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

ECT

Blinding Strategy

DOUBLE

Interventions

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sodium nitroprusside, bradykinin, acetylcholine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age: 18 - 70
* gender: male
* good state of health

Exclusion Criteria

* known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, homocysteinemia)
* regular medication and/or treatment with drugs within the last 4-6 weeks (exclusion has to be decided in each case)
* acute or chronic illness
* methylxanthines and alcohol during 12 hours before the study
* nicotine during 1 year before the study
* drug and/or alcohol abuse
* pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Walter E Haefeli, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Internal Medicine VI, University of Heidelberg

Locations

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Dept. of Internal Medicine VI

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Walter E Haefeli, MD

Role: CONTACT

Phone: +49-6221-56-

Email: [email protected]

References

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Fricker R, Hesse C, Weiss J, Tayrouz Y, Hoffmann MM, Unnebrink K, Mansmann U, Haefeli WE. Endothelial venodilator response in carriers of genetic polymorphisms involved in NO synthesis and degradation. Br J Clin Pharmacol. 2004 Aug;58(2):169-77. doi: 10.1111/j.1365-2125.2004.02130.x.

Reference Type BACKGROUND
PMID: 15255799 (View on PubMed)

Other Identifiers

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K004

Identifier Type: -

Identifier Source: org_study_id