Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls

June 24, 2006 updated by: Regional Hospital Holstebro

Phase 1 Study of the Effects of Systemic Nitric Oxide Inhibition With Ng-Monomethyl-L-Arginine on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls

The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in essential hypertension by investigating the effects of a non selective nitric oxide inhibitor on renal hemodynamics and sodium excretion in patients with essential hypertension. The results are compared with a group of healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study investigates the effects of Ng-monomethyl-L-arginine (L-NMMA) on:

  1. renal hemodynamics (renal plasma flow and glomerular filtration rate)
  2. renal sodium excretion
  3. lithium clearance and fractional lithium excretion
  4. plasma levels of vasoactive hormones
  5. blood pressure and heart rate

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Essential hypertension (blood pressure > 140/90) with no signs of secondary hypertension
  • P-creatinine < 200 µmol/L

Exclusion Criteria:

  • Anamnestic or clinical signs of heart disease, renal disease, liver disease, neoplastic disease, anemia or cerebro-vascular insult
  • Medication except antihypertensives
  • Drug or alcohol abuse
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Holstebro

Investigators

  • Study Chair: Erling B Pedersen, Professor, Holstebro Hospital, 7500 Holstebro, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 24, 2006

First Submitted That Met QC Criteria

June 24, 2006

First Posted (Estimate)

June 27, 2006

Study Record Updates

Last Update Posted (Estimate)

June 27, 2006

Last Update Submitted That Met QC Criteria

June 24, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED.RES.HOS.1995.01.JNB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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