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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00344734
First Posted: June 27, 2006
Last Update Posted: June 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Regional Hospital Holstebro
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344734


Sponsors and Collaborators
Regional Hospital Holstebro
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

ClinicalTrials.gov Identifier: NCT00344734     History of Changes
Other Study ID Numbers: MED.RES.HOS.1997.03.JNB
First Submitted: June 24, 2006
First Posted: June 27, 2006
Last Update Posted: June 27, 2006
Last Verified: June 2006

Keywords provided by Regional Hospital Holstebro:
Nitric oxide
Renal hemodynamics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Hormones
omega-N-Methylarginine
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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