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

NCT00344734 | Completed Phase 1

• 1 other identifier: MED.RES.HOS.1997.03.JNB
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congestive Heart Failure

Keywords

Nitric oxide; Renal hemodynamics

Interventions

Ng-monomethyl-L-arginine (drug) DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regional Hospital Holstebro: lead

MeSH Terms

Conditions

Heart Failure

Interventions

omega-N-Methylarginine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Arginine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Jesper N Bech, MD, Ph.D.

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

  PRINCIPAL INVESTIGATOR

• Erling B Pedersen, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2006
• First Posted: June 27, 2006
• Last Updated: June 27, 2006

Record last verified: 2006-06