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Vasoreactivity in Carriers of Genetic Polymorphisms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00160888
First received: September 8, 2005
Last updated: September 9, 2005
Last verified: September 2005
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: sodium nitroprusside, bradykinin, acetylcholine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Endothelium-Dependent Vasoreactivity in Nitric Oxide Synthase Gene (Glu298Asp) Polymorphism: Studies in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Study I: Venous responsiveness assessed by dorsal hand vein compliance technique
  • Study II: Forearm blood flow assessed by venous occlusion plethysmography

Estimated Enrollment: 100
Study Start Date: November 1999
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160888

Contacts
Contact: Walter E Haefeli, MD +49-6221-56- ext 8740 Walter_Emil_Haefeli@med.uni-heidelberg.de

Locations
Germany
Dept. of Internal Medicine VI Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Walter E Haefeli, MD Dept. of Internal Medicine VI, University of Heidelberg
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00160888     History of Changes
Other Study ID Numbers: K004
Study First Received: September 8, 2005
Last Updated: September 9, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Acetylcholine
Bradykinin
Nitroprusside
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nitric Oxide Donors
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 16, 2013