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Completed

NCT Number: NCT02150694

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vascular Research Unit

Cambridge, CB2 0QQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forearm Venous Occlusion Plethysmography

Procedure

Forearm venous occlusion plethysmography to study to measure forearm blood flow during intra-arterial infusion of the apelin peptides.

Aellig hand vein technique

Procedure

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

Other

Escalating doses of apelin (1/10/100nmol/min) will be administered.

Apelin receptor antagonist infusion

Other

Dose finding study (range 1-300nmol/min) and co-infusion study with apelin peptides

Primary outcomes

  1. Forearm blood flow measured by forearm plethysmography in response to infused vasodilators

    Time frame: 2-3 hours

  2. Change in hand vein diameter measured by Aellig hand vein technique, in response to study peptides

    Time frame: 2-3 hours

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Registry information

Acronym: HEAP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 30, 2014
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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