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

Sponsored by:	Holstebro Hospital
Information provided by:	Holstebro Hospital
ClinicalTrials.gov Identifier:	NCT00344734

Purpose

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.

Condition	Intervention	Phase
Congestive Heart Failure	Drug: Ng-monomethyl-L-arginine (drug)	Phase I

MedlinePlus related topics: Dietary Sodium Heart Failure

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

U.S. FDA Resources

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

Further study details as provided by Holstebro Hospital:

Estimated Enrollment:

30

Detailed Description:

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

Eligibility

Ages Eligible for Study:	20 Years to 75 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344734

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

More Information

Study ID Numbers:	MED.RES.HOS.1997.03.JNB
Study First Received:	June 24, 2006
Last Updated:	June 24, 2006
ClinicalTrials.gov Identifier:	NCT00344734
Health Authority:	Denmark: National Board of Health

Keywords provided by Holstebro Hospital:

Nitric oxide
Renal hemodynamics

Study placed in the following topic categories:

Nitric Oxide
Heart Failure
Heart Diseases
Omega-N-Methylarginine
Healthy

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009