Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Regional Hospital Holstebro
Treatments:
Hormones
omega-N-Methylarginine
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