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CompletedNCT00344734Updated Jun 27, 2006

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

A Phase 1 interventional study of Ng-monomethyl-L-arginine (drug) in Congestive Heart Failure, sponsored by Regional Hospital Holstebro. Completed. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-06-27.

Sponsored by Regional Hospital Holstebro · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Congestive Heart Failure

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Keywords

  • Nitric oxide
  • Renal hemodynamics
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 30 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

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Lead sponsor

Regional Hospital Holstebro is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
30 participants

Interventions

  • DrugNg-monomethyl-L-arginine (drug)
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00344734
Lead sponsor
Regional Hospital Holstebro
First posted
Jun 27, 2006
Last update
Jun 27, 2006

Study contacts

Jesper N Bech, MD, Ph.D.
principal investigator · Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Erling B Pedersen, Professor
study chair · Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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