Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis - Full Text View

Sponsored by:	Holstebro Hospital
Information provided by:	Holstebro Hospital
ClinicalTrials.gov Identifier:	NCT00344916

Purpose

Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is increased in liver cirrhosis.

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

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Placebo Control, Crossover Assignment
Official Title:	NO-Synthesis in Patients With Liver Cirrhosis: Effect of L-NMMA on Renal Hemodynamics, Sodium Excretion and Plasma Levels of Vasoactive Hormones

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis

Drug Information available for: omega-N-Methylarginine Arginine

U.S. FDA Resources

Further study details as provided by Holstebro Hospital:

Estimated Enrollment:

30

Detailed Description:

In a randomized, placebo controlled design the acute effects of Ng-monomethyl-L-arginine are studied on:

renal hemodynamics (GFR and RPF)
blood pressure and heart rate
lithium clearance
plasma levels of vasoactive hormones

Eligibility

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

Criteria

Inclusion Criteria:

Healthy controls

Age 20 to 60 years
Both men and women
Weight below 100 kg
Normal clinical examination and laboratory screening
Fertile women only if using contraception
Informed consent according to the regulations of the local ethics committee

Liver cirrhosis

Biopsy verified liver cirrhosis or clinical and laboratory signs of liver cirrhosis including hypoalbuminaemia, increased prothrombin time in combination with esophagusvarices or ascites
P-creatinine < 250 µmol/L
Age 20-60 years
Both men and women
Fertile women only if using contraception
Body weight below 100 kg
Informed consent according to the regulations of the local ethics committee

Exclusion Criteria:

Healthy controls

History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
Current medication
Drugs or alcohol abuse
Pregnancy
Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
Donation of blood less than 1 month before the experiments

Liver cirrhosis

Apart from liver cirrhosis no history of diseases of the heart and blood vessels, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
Drugs or alcohol abuse
Pregnancy
Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344916

Sponsors and Collaborators

Holstebro Hospital

Investigators

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

More Information

No publications provided

Study ID Numbers:	MED.RES.HOS.1996.04.JNB
Study First Received:	June 24, 2006
Last Updated:	July 10, 2006
ClinicalTrials.gov Identifier:	NCT00344916 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Holstebro Hospital:

Renal hemodynamics
Nitric oxide

Study placed in the following topic categories:

Nitric Oxide
Liver Diseases
Digestive System Diseases
Arginine

Fibrosis
Omega-N-Methylarginine
Liver Cirrhosis
Hormones

Additional relevant MeSH terms:

Liver Diseases
Pathologic Processes
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Fibrosis

Omega-N-Methylarginine
Enzyme Inhibitors
Liver Cirrhosis
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009