Vasoreactivity in Carriers of Genetic Polymorphisms

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00160888
• Other study ID #: K004
• Status: Recruiting
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: September 9, 2005
• Start date: November 1999
• Est. completion date: December 2006

Study information

• Verified date: September 2005
• Source: Heidelberg University
• Contact: Walter E Haefeli, MD
• Phone: +49-6221-56-
• Email: Walter_Emil_Haefeli[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• sodium nitroprusside, bradykinin, acetylcholine

Locations

Country	Name	City	State
Germany	Dept. of Internal Medicine VI	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study I: Venous responsiveness assessed by dorsal hand vein compliance technique
Primary	Study II: Forearm blood flow assessed by venous occlusion plethysmography