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

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Procedure: Forearm venous occlusion plethysmography; Procedure: Aellig hand vein technique; Other: Apelin receptor antagonist infusion; Other: Apelin agonist infusion

• Registration Number: NCT02150694
• Lead Sponsor: University of Cambridge

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-05
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-29
• Last Update Submitted: 2014-05-29
• Study First Posted: 2014-05-30
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Apelin agonist infusion	Forearm venous occlusion plethysmography	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.
Apelin receptor antagonist infusion	Aellig hand vein technique	Aellig hand vein technique will be used to investigate the change in vein diameter in response to an apelin blocking agent
Apelin receptor antagonist infusion	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
Apelin agonist/antagonist co-infusion	Forearm venous occlusion plethysmography	Forearm blood flow study to measure blood flow by forearm venous occlusion plethysmography following intraarterial infusion of apelin receptor agonists and antagonist.
Apelin agonist/antagonist co-infusion	Apelin agonist infusion	Forearm blood flow study to measure blood flow by forearm venous occlusion plethysmography following intraarterial infusion of apelin receptor agonists and antagonist.
Apelin agonist/antagonist co-infusion	Apelin receptor antagonist infusion	Forearm blood flow study to measure blood flow by forearm venous occlusion plethysmography following intraarterial infusion of apelin receptor agonists and antagonist.
Apelin agonist infusion	Aellig hand vein technique	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.
Apelin agonist infusion	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.

Primary Outcome Measures

Name	Time	Method
Forearm blood flow measured by forearm plethysmography in response to infused vasodilators	2-3 hours
Change in hand vein diameter measured by Aellig hand vein technique, in response to study peptides	2-3 hours

Trial Locations

Locations (1)

Vascular Research Unit; 🇬🇧 Cambridge, United Kingdom