Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo
NCT ID: NCT02150694
Last Updated: 2014-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2012-01-31
2013-08-31
Brief Summary
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The investigators have devised 2 sets of experiments to investigate how the apelins affect blood vessels.
In the first group of experiments,the investigators will give healthy volunteers up to 3 different apelin substances, and use special research techniques to see how they affect the way that blood vessels work in the forearm.
In the second group of experiments, the apelins will be given along with another form of apelin which blocks the effects of apelin in laboratory experiments. The investigators want to see if it blocks the effects of apelin in healthy humans.
The investigators intend to test the hypothesis that:
Apelin agonists are vasodilators in human resistance vessels, this effect will be blocked by an apelin receptor antagonist.
This study will help us to understand more about how apelins work, and to suggest how they might be used to treat heart disease.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Apelin agonist infusion
Studies to measure change in blood flow in response to apelin agonists (1/10/100nmol) using forearm venous occlusion plethysmography and Aellig hand vein technique.
Forearm venous occlusion plethysmography
Forearm venous occlusion plethysmography to study to measure forearm blood flow during intra-arterial infusion of the apelin peptides.
Aellig hand vein technique
Hand vein measurements will be used to assess the response to apelin peptides and apelin receptor blocker in the human hand vein vascular bed.
Apelin agonist infusion
Escalating doses of apelin (1/10/100nmol/min) will be administered.
Apelin receptor antagonist infusion
Aellig hand vein technique will be used to investigate the change in vein diameter in response to an apelin blocking agent
Aellig hand vein technique
Hand vein measurements will be used to assess the response to apelin peptides and apelin receptor blocker in the human hand vein vascular bed.
Apelin receptor antagonist infusion
Dose finding study (range 1-300nmol/min) and co-infusion study with apelin peptides
Apelin agonist/antagonist co-infusion
Forearm blood flow study to measure blood flow by forearm venous occlusion plethysmography following intraarterial infusion of apelin receptor agonists and antagonist.
Forearm venous occlusion plethysmography
Forearm venous occlusion plethysmography to study to measure forearm blood flow during intra-arterial infusion of the apelin peptides.
Apelin agonist infusion
Escalating doses of apelin (1/10/100nmol/min) will be administered.
Apelin receptor antagonist infusion
Dose finding study (range 1-300nmol/min) and co-infusion study with apelin peptides
Interventions
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Forearm venous occlusion plethysmography
Forearm venous occlusion plethysmography to study to measure forearm blood flow during intra-arterial infusion of the apelin peptides.
Aellig hand vein technique
Hand vein measurements will be used to assess the response to apelin peptides and apelin receptor blocker in the human hand vein vascular bed.
Apelin agonist infusion
Escalating doses of apelin (1/10/100nmol/min) will be administered.
Apelin receptor antagonist infusion
Dose finding study (range 1-300nmol/min) and co-infusion study with apelin peptides
Eligibility Criteria
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Inclusion Criteria
* Non-regular smoking (\<5 cigarettes per week)
* If female, postmenopausal or on days 2-9 of menstrual cycle
Exclusion Criteria
* Ischaemic Heart Disease
* Renal, respiratory or neurological disease
* Diabetes mellitus
* BMI \>30, BMI \<18
* Pregnant
* Smoker
* Use of vasoactive medication or NSAIDS/aspirin within 48 hours of study.
* Current involvement in other research studies
18 Years
70 Years
ALL
Yes
Sponsors
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University of Cambridge
OTHER
Responsible Party
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Dr Aimee Brame MRCP
Research Fellow
Principal Investigators
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Ian B Wilkinson, FRCP DM
Role: STUDY_DIRECTOR
University of Cambridge
Anthony P Davenport, MA PhD
Role: STUDY_DIRECTOR
University of Cambridge
Locations
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Vascular Research Unit
Cambridge, , United Kingdom
Countries
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Other Identifiers
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HEAP Study
Identifier Type: -
Identifier Source: org_study_id