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

June 24, 2006 updated by: Regional Hospital Holstebro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Holstebro

Investigators

  • Study Chair: Erling B Pedersen, Professor, Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 24, 2006

First Submitted That Met QC Criteria

June 24, 2006

First Posted (ESTIMATE)

June 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2006

Last Update Submitted That Met QC Criteria

June 24, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED.RES.HOS.1997.03.JNB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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