Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers - Protocol 4

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Heart Failure
• Interventions: Drug: Urocortin 3; Drug: Urocortin 2

• Registration Number: NCT01296607
• Lead Sponsor: University of Edinburgh

Brief 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 pharmacokinetics and pharmacodynamics (in particular the onset-offset of action and reproducibility of vasodilator effects) of Urocortins 2 \& 3 on forearm arterial blood flow healthy volunteers.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-31
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Urocortin 3	Urocortin 3	This arm studies the onset/ offset of action and the reproducibility of effect on forearm blood flow of of intra-arterial Urocortin 3 in the presence and absence of a saline washout between incremental doses.
Urocortin 2	Urocortin 2	This arm studies the onset/ offset of action and the reproducibility of effect on forearm blood flow of of intra-arterial Urocortin 2 in the presence and absence of a saline washout between incremental doses.

Primary Outcome Measures

Name	Time	Method
Forearm blood flow	3.5 hours	Difference in forearm blood flow in response to increasing doses of Urocortin 2 and Urocortin 3 in the presence and absence of saline washout between doses

Secondary Outcome Measures

Name	Time	Method
Plasma Urocortin 2 and 3 levels	3.5 hours	Change in plasma levels of Urocortin 2 and 3 in response to intra-arterial infusion of Urocortin 2 and 3 respectively.

Trial Locations

Locations (1)

Wellcome Trust Clinical Research Facility, Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Mid Lothian, United Kingdom