HEAP: Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo

• Sponsor: University of Cambridge (Other)
• Overall Status: Completed
• CT.gov ID: NCT02150694
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 3
• Duration (Months): 19
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

Apelins are substances which occur naturally in the body, and have an important role in heart disease. They have been shown to make blood vessels dilate, and improve the way the heart works.

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Procedure: Forearm venous occlusion plethysmography; Procedure: Aellig hand vein technique; Other: Apelin agonist infusion; Other: Apelin receptor antagonist infusion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Forearm venous occlusion plethysmography; Forearm venous occlusion plethysmography to study to measure forearm blood flow during intra-arterial infusion of the apelin peptides.; Procedure: 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.; Other: Apelin agonist infusion; Escalating doses of apelin (1/10/100nmol/min) will be administered.
Experimental: 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	Procedure: 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.; Other: Apelin receptor antagonist infusion; Dose finding study (range 1-300nmol/min) and co-infusion study with apelin peptides
Experimental: 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.	Procedure: Forearm venous occlusion plethysmography; Forearm venous occlusion plethysmography to study to measure forearm blood flow during intra-arterial infusion of the apelin peptides.; Other: Apelin agonist infusion; Escalating doses of apelin (1/10/100nmol/min) will be administered.; Other: Apelin receptor antagonist infusion; Dose finding study (range 1-300nmol/min) and co-infusion study with apelin peptides

Outcome Measures

Primary Outcome Measures

1. Forearm blood flow measured by forearm plethysmography in response to infused vasodilators [2-3 hours]

2. Change in hand vein diameter measured by Aellig hand vein technique, in response to study peptides [2-3 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Between 18 and 70 years

• Non-regular smoking (<5 cigarettes per week)

• If female, postmenopausal or on days 2-9 of menstrual cycle

Exclusion Criteria:

• Hypertension (sustained BP >160/100mmHg)

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vascular Research Unit	Cambridge		United Kingdom	CB2 0QQ

Sponsors and Collaborators

• University of Cambridge

Investigators

• Study Director: Ian B Wilkinson, FRCP DM, University of Cambridge
• Study Director: Anthony P Davenport, MA PhD, University of Cambridge

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Aimee Brame MRCP, Research Fellow, University of Cambridge
• ClinicalTrials.gov Identifier: NCT02150694
• Other Study ID Numbers: HEAP Study
• First Posted: May 30, 2014
• Last Update Posted: May 30, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of May 30, 2014