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

University of Cambridge

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Procedure: Forearm venous occlusion plethysmography; Other: Apelin agonist infusion; Procedure: Aellig hand vein technique; Other: Apelin receptor antagonist infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02150694

HEAP Study

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 3 patient groups

Apelin agonist infusion

Experimental group

Description:

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.

Treatment:

Procedure: Aellig hand vein technique

Other: Apelin agonist infusion

Procedure: Forearm venous occlusion plethysmography

Apelin receptor antagonist infusion

Experimental group

Description:

Aellig hand vein technique will be used to investigate the change in vein diameter in response to an apelin blocking agent

Treatment:

Procedure: Aellig hand vein technique

Other: Apelin receptor antagonist infusion

Apelin agonist/antagonist co-infusion

Experimental group

Description:

Forearm blood flow study to measure blood flow by forearm venous occlusion plethysmography following intraarterial infusion of apelin receptor agonists and antagonist.

Treatment:

Other: Apelin agonist infusion

Procedure: Forearm venous occlusion plethysmography

Other: Apelin receptor antagonist infusion