Vasoreactivity in Carriers of Genetic Polymorphisms

Condition(s) targeted: Healthy

Intervention: sodium nitroprusside, bradykinin, acetylcholine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Heidelberg University

Official(s) and/or principal investigator(s):
Walter E Haefeli, MD, Principal Investigator, Affiliation: Dept. of Internal Medicine VI, University of Heidelberg

Overall contact:
Walter E Haefeli, MD, Phone: +49-6221-56-, Ext: 8740, Email: Walter_Emil_Haefeli@med.uni-heidelberg.de

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.

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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Primary outcome:

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

Study II: Forearm blood flow assessed by venous occlusion plethysmography

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Walter E Haefeli, MD, Phone: +49-6221-56-, Ext: 8740, Email: Walter_Emil_Haefeli@med.uni-heidelberg.de

Dept. of Internal Medicine VI, Heidelberg, Baden-Württemberg 69120, Germany; Recruiting

Related publications:

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.

Starting date: November 1999
Last updated: September 9, 2005