None listed
Conditions
Brief summary
Urocortin 2 is a recently discovered peptide present in human plasma which may play an important role in cardiovascular control. In animals it has been shown to relax arteries, increase blood flow to the heart and the amount of blood the heart pumps confirming it's role in cardiovascular physiology. We plan to measure plasma concentrations of Urocortin 2 in normal subjects and patients with stable left ventricular dysfunction. We also plan to assess the effect of low dose infusions of Urocortin 2 in normal volunteers and subjects with stable left ventricular dysfunction. Arterial pressure and cardiac output will be measured non-invasively, blood samples to assess its hormonal interactions and urine samples to assess the effect of Urocortin 2 on urine volume and sodium excretion will be collected.
Interventions
UROCORTIN 2 at doses of 25mcg and 100mcg infused intravenously, over 1 hour, in random order, two weeks apart.
Sponsors
National Heart Foundation New Zealand
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Able to read, understand, and provide written informed consent before participating in the study- willing to remain in the study facility for approximately 16 hours on 2 occasions and return for follow-up as needed- willing to comply with all study procedures throughout the study:Additional Inclusion Criteria for CHF patients- Class II CHF and aged 18-72 inclusive.
Exclusion criteria
Volunteers who meet any one of the following criteria will be excluded from the study- any unstable medical abnormality, chronic disease, or history or presence of neurological (including cognitive disorders), hepatic, renal, cardiovascular (does not apply to CHF patients), gastrointestinal, pulmonary, or endocrine disease , or any other abnormality that could interfere with the pharmacokinetics or pharmacodynamics evaluations of the study drug- any abnormalities in cardiovascular history (does not apply to CHF patients)- a history of malignancy- an unstable psychological disorder according to DSM-IV criteria within the past year -a history of inability to comply fully with all procedural aspects of this study (-a clinically significant illness within 30 days before dosing-a clinically significant abnormal finding upon physical examination, ECG, or clinical laboratory testing as determined by the investigator -consumed more than two alcoholic beverages per day or more than 14 alcoholic beverages per week within 14 days of dosing- consumed alcohol within 48 hours before dosing- used nicotine-containing products (including, but not limited to, tobacco, gum, patches) within 90 days before dosing - used steroids, corticosteriods, or glucocorticosteriods by any route of administration on a chronic or regular basis within 3 months before dosing -used any prescription medication or OTC medication within 72 hours before dosing - used alternative remedies or supplements within 48 hours before dosing -used any investigational drug within 1 month before dosing-had a significant blood loss greater than 500 mL or donated blood within 30 days of dosing -a positive test result for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) or history of a positive result-a positive alcohol plasma sample or urine drug screen result at screening or at baseline -currently abusing analgesics, tranquilizers, opioids, mood-altering drugs, or have a known drug dependence according to DSM-IV criteria-allergy, hypersensitivity, or intolerance to UROCORTIN 2.
Outcome results
None listed