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

This study has been completed.

First Received: June 24, 2006 No Changes Posted

Sponsored by:	Holstebro Hospital
Information provided by:	Holstebro Hospital
ClinicalTrials.gov Identifier:	NCT00345150

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Ng-monomethyl-L-arginine (drug)	Phase I

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Placebo Control, Crossover Assignment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Nitric oxide omega-N-Methylarginine Arginine Arginine hydrochloride

U.S. FDA Resources

Further study details as provided by Holstebro Hospital:

Estimated Enrollment:

Detailed Description:

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

renal hemodynamics (renal plasma flow and glomerular filtration rate)
renal sodium excretion
lithium clearance and fractional lithium excretion
plasma levels of vasoactive hormones
blood pressure and heart rate

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345150

Sponsors and Collaborators

Holstebro Hospital

Investigators

Principal Investigator:	Jesper N Bech, MD, Ph.D.	Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Study Chair:	Erling B Pedersen, Professor	Holstebro Hospital, 7500 Holstebro, Denmark

More Information

No publications provided

Study ID Numbers:	MED.RES.HOS.1995.01.JNB
Study First Received:	June 24, 2006
Last Updated:	June 24, 2006
ClinicalTrials.gov Identifier:	NCT00345150 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Holstebro Hospital:

hypertension
nitric oxide
renal hemodynamics

Study placed in the following topic categories:

Nitric Oxide
Essential Hypertension
Arginine
Omega-N-Methylarginine

Vascular Diseases
Healthy
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Omega-N-Methylarginine
Vascular Diseases
Enzyme Inhibitors

Cardiovascular Diseases
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009