A Phase 2 interventional study of Urotensine II and Soluble epoxide hydrolase in Heart Failure, sponsored by Monash University. Completed at 1 site in Australia. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-20.
Sponsored by Monash University · Phase 2, Interventional, and Basic science
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 therefore may be involved in important diseases such as chronic heart failure - CHF (weak heart muscle disease). Many vasoconstrictors have been found to have effects on key organs such as the heart. Preliminary data by our group have demonstrated this is true of U-II. Recent evidence shows that in CHF, U-II levels in the blood are increased.
The proposed study seek to determine the effect of blocking a possible downstream mediator of U-II on blood vessels by administration of soluble epoxide hydrolase inhibitor (sEHI). There will be 2 study groups 1) Healthy volunteers and, 2) CHF patients.
Each arm of the study will run independently and will require 16 participants each (16 normal subjects and 16 CHF subjects). Participants will be screened to ensure that they are eligible. CHF patients will be required to withdraw from their CHF medication 24 hours prior to the study day (except for diuretics). On the study day, sEHI will be administered on the skin of participants in 3 asceding dosages. The technique to be used is iontophoresis. This is a non invasive technique in which a small amount of the compound is placed on the skin of the forearm. The drug is delivered across the skin by passing a small electric current over the area. The change in blood flow is then measured and analysed. We will also administer U-II agonist, noradrenaline, and distilled water (all via iontophoresis). Noradrenaline will be used a positive constrictor control. Change in blood flow will be assessed by Laser Doppler Velocimetry.
If it is found that the sEHI is able to prevent blood vessel constriction in CHF patients, then it may represent a major therapeutic advance in the management of CHF.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 16 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Monash University is the lead sponsor of 81 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Heart failure patients
Drug: Urotensine II · Drug: Soluble epoxide hydrolase
Healthy subjects
Drug: Urotensine II · Drug: Soluble epoxide hydrolase
A few drops of the drug will be administered to the skin by iontophoresis.
A few drops of the drug will be administered to the skin by iontophoresis.
To compare the vasoactive role of Soluble epoxide hydrolase in the healthy subjects and CHF patients with iontophoresis.
Time frame: 2 hours
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Monash University