Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers
Information source: University of Edinburgh
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vascular Disease; Heart Disease
Intervention: Astressin 2B (Drug); Mannitol (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Edinburgh Official(s) and/or principal investigator(s):
David E Newby, PhD FRCP, Principal Investigator, Affiliation: University of Edinburgh
Overall contact:
Sowmya Venkatasubramanian, MBBS, MRCP, Phone: 0044 131 242 6364, Email: s.venkat@ed.ac.uk
Summary
Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem
with a poor prognosis and the search for novel treatments remains an important area of
research.
Urocortins are proteins that appear to increase blood flow and heart pumping activity. There
has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in
heart failure.
In this study, we will examine the effects and mechanisms of Urocortins 2 & 3 and the
Corticotrophin Releasing Hormone Receptor Type 2 (CRH-R2) receptor (through which urocortins
act) on forearm blood flow and release of natural blood clot dissolving factors in the
forearm circulation of healthy volunteers.
In this study, we will look at the role of the lining of the blood vessel (endothelium) in
response to urocortin types 2 and 3. We hypothesise that urocortins 2 & 3 act via the
endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen
activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a
role in maintaining the normal baseline level of blood flow in forearm arteries. In addition
to the above, we will also look at the effect of temporarily blocking the effect of
urocortins, using a specially designed blocker drug (Astressin 2B).
Utilising the well-established technique of 'forearm venous occlusion plethysmography', we
will be able to focus on the local effects of urocortins on arterial blood flow in forearm
vessels, without affecting this system in the body as a whole.
Clinical Details
Official title: Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Change in forearm blood flow
Secondary outcome: Principle safety assessment, heart rate and blood pressure
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy male volunteers between 18 - 65 years (inclusive)
Exclusion Criteria:
- Lack of informed consent
- Age <18 years > 65 years
- Current involvement in a clinical trial
- Severe or significant co-morbidity including bleeding diathesis, renal or hepatic
failure
- Smoker
- History of anaemia
- Recent infective/inflammatory condition
- Recent blood donation (prior 3 months)
- Positive baseline urine test for drugs of abuse (including cannabinoids,
benzodiazepines, opiates, cocaine and amphetamines)
Locations and Contacts
Sowmya Venkatasubramanian, MBBS, MRCP, Phone: 0044 131 242 6364, Email: s.venkat@ed.ac.uk
Wellcome Trust Clinical Research Facility, Royal Infirmary of Edinburgh, Edinburgh, Mid Lothian EH16 4SA, United Kingdom
Additional Information
Starting date: April 2010
Last updated: March 30, 2010
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