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Clinical Trials/NCT00160888
NCT00160888
Unknown
Phase 1

Endothelium-Dependent Vasoreactivity in Nitric Oxide Synthase Gene (Glu298Asp) Polymorphism: Studies in Healthy Volunteers

Heidelberg University1 site in 1 country100 target enrollmentNovember 1999

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Healthy
Sponsor
Heidelberg University
Enrollment
100
Locations
1
Primary Endpoint
Study I: Venous responsiveness assessed by dorsal hand vein compliance technique
Last Updated
20 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 1999
End Date
December 2006
Last Updated
20 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Study I: Venous responsiveness assessed by dorsal hand vein compliance technique

Study II: Forearm blood flow assessed by venous occlusion plethysmography

Study Sites (1)

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