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

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00344916
First received: June 24, 2006
Last updated: July 10, 2006
Last verified: June 2006
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
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:


Further study details as provided by Regional Hospital Holstebro:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Regional Hospital Holstebro
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

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

Keywords provided by Regional Hospital Holstebro:
Renal hemodynamics
Nitric oxide

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Omega-N-Methylarginine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014