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

This study has been completed.

Sponsor:

Information provided by:

Regional Hospital Holstebro

ClinicalTrials.gov Identifier:

NCT00344734

First received: June 24, 2006

Last updated: NA

Last verified: June 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 24, 2006

Last Updated Date

June 24, 2006

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: Ng-monomethyl-L-arginine (drug)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00344734

Other Study ID Numbers ^ICMJE

MED.RES.HOS.1997.03.JNB

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Regional Hospital Holstebro

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Regional Hospital Holstebro

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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