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

Cardiovascular Disease Clinical Trial

— HEAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150694
• Other study ID #: HEAP Study
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: May 29, 2014
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Procedure:
• 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.

Other:
• 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

Locations

Country	Name	City	State
United Kingdom	Vascular Research Unit	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm blood flow measured by forearm plethysmography in response to infused vasodilators		2-3 hours	No
Primary	Change in hand vein diameter measured by Aellig hand vein technique, in response to study peptides		2-3 hours	No