Status:
COMPLETED
Evaluation of the Effects of Urotensin-II and Soluble Epoxide Hydrolase Inhibitors on Skin Microvessel Tone in Patients With Heart Failure, and in Healthy Volunteers
Lead Sponsor:
Monash University
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Urotensin II (U-II) is newly discovered protein that may play an important role in human health and disease. U-II has been found to be a potent vasoconstrictor (narrower of blood vessels) which theref...
Eligibility Criteria
Inclusion
- Confirmed written informed consent.
- Male/Female over 18 and under 80 years of age.
- Females must be non-pregnant, non-lactating and using reliable means of contraception (surgical sterilisation or a barrier method such as a condom). The oral contraceptive pill is an exclusion to this study.
- Patients with CHF will be required to have left ventricular fractional shortening \[LVFS\] of \<22% or LVEF \< 40% and New York Heart Association functional class \[NYHA FC\] II-III symptoms
- Body mass index (BMI) between 18-35 kg/m2.
- Screening clinical laboratory tests including liver function tests and HbA1c are within the normal reference range for the investigative site.
- Electrocardiogram (ECG) results considered within normal limits, as determined by the Investigator.
Exclusion
- Smokers
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, or other disorders capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk factor when exposed to the study medication.
- Those requiring concomitant medications that will affect cardiovascular or endothelial function or blood pressure control (eg cholesterol lowering medication, hormone replacement therapy, aspirin, NSAIDS).
- Patients receiving Hormone Replacement Therapy.
- Known allergy or hypersensitivity to urotensin or urotensin receptor antagonists or its excipients, or related drugs, or a history of relevant adverse drug reactions of any origin.
- Regular alcohol intake greater than 14 units/week or is unwilling to comply with the alcohol prohibition for the duration of the study (1 unit of alcohol is equivalent to: 12 ounces of beer, 4 ounces of wine, or 1 ounce of 50-proof hard liquor).
- History of drug abuse.
- Screening biochemistry \> 20 % outside normal limits.
- Patients who are thought to be terminally ill or immuno-compromised
- Patients who have previously been enrolled in this study or have received other experimental medications in the last 4 weeks.
- Patients who are unlikely to comply with study procedures
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00654966
Start Date
June 1 2009
End Date
December 1 2010
Last Update
July 20 2011
Active Locations (1)
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1
Alfred Hospital
Melbourne, Victoria, Australia, 3004