NCT00160888

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 1999

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 9, 2005

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  • Study II: Forearm blood flow assessed by venous occlusion plethysmography

Interventions

sodium nitroprusside, bradykinin, acetylcholineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, smoking, homocysteinemia)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Internal Medicine VI

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related 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. doi: 10.1111/j.1365-2125.2004.02130.x.

    PMID: 15255799BACKGROUND

MeSH Terms

Interventions

NitroprussideBradykininAcetylcholine

Intervention Hierarchy (Ancestors)

FerricyanidesCyanidesAnionsIonsElectrolytesInorganic ChemicalsFerric CompoundsIron CompoundsHydrogen CyanideNitrogen CompoundsKininsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsNeuropeptidesOligopeptidesProteinsNerve Tissue ProteinsAutacoidsInflammation MediatorsBiological FactorsBiogenic AminesAminesOrganic Chemicals

Study Officials

  • Walter E Haefeli, MD

    Dept. of Internal Medicine VI, University of Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter E Haefeli, MD

CONTACT

+49-6221-56-Walter_Emil_Haefeli@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

November 1, 1999

Study Completion

December 1, 2006

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations

DE(1)