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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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

Conditions

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Liver Cirrhosis

Keywords

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Renal hemodynamics Nitric oxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Interventions

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Ng-monomethyl-L-arginine (drug)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Erling B Pedersen, Professor

Role: STUDY_CHAIR

Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark

Jesper N Bech, MD, Ph.d.

Role: PRINCIPAL_INVESTIGATOR