Effects of Acute L-NMMA Treatment on Renal Hemodynamics and Vasoactive Hormones in Patients With Congestive Heart Failure

The study tests the hypothesis that nitric oxide availability is changed in congestive heart failure with regard to the regulation of renal hemodynamics, renal sodium excretion and release of vasoactive hormones. The study tests these hypotheses by comparing the effects of systemic nitric oxide inhibition with L-NMMA in congestive heart failure patients with healthy subjects on renal hemodynamics, blood pressure and plasma levels of vasoactive hormones.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

The purpose of the study is to investigate the effects of systemic treatment with Ng-monomethyl-l-arginine in congestive heart failure and healthy controls on:

glomerular filtration rate and renal plasma flow
blood pressure and heart rate
plasma levels of vasoactive hormones
lithium clearance

The study is randomized and placebo controlled

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Heart failure

Both men and women
Age 20 to 75 years
Patients with heart failure in NYHA group II-III. Heart failure must be derived from ischaemic heart disease or dilated cardiomyopathy. Diagnosis must be verified by history and echocardiography or isotope cardiography.
ejection fraction < 0.40
P-creatinin < 250 µmol/L
Fertile women only if using contraception
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

Heart failure

Cardiac valvular disease with stenosis
Significant cardiac arrythmia
Myocardial infarction, PTCA or by-pass surgery less than 3 months before the study
Diseases of the lever, kidneys, lungs or endocrine organs which are not secondary to congestive heart failure
Arterial hypertension
Neoplastic disease
Cerebrovascular insult
Treatment with ACE-inhibitors or nitrates which cannot be stopped 1 week before study

Treatment and study plan

Ng-monomethyl-L-arginine (drug)

Drug

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

Effects of Acute L-NMMA Treatment on Renal Hemodynamics, Sodium and Water Excretion and Plasma Levels of Vasoactive Hormones in Patients With Congestive Heart Failure and Healthy Controls

Important dates

First posted: Jun 27, 2006
Registry last updated: Jun 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed