Interaction of Apelin and Angiotensin in the Human Forearm Circulation

NCT00901745 | Completed

• 1 other identifier: FS/09/019/26905 - 1b
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease. Apelin has the ability to cause blood vessels to relax, increasing their diameter and hence blood flow down the blood vessel. The researchers wish to investigate the hypothesis that an infusion of apelin will reduce the effects of angiotensin II, which is know to reduce the diameter of blood vessels.

Conditions

Heart Disease; Vasodilation

Keywords

Renin angiotensin system; Apelin; Vasodilatation; Heart disease; Vascular biology

Outcome Measures

Primary Outcomes (1)

• Change in angiotensin II mediated vasoconstriction

  12 months

Secondary Outcomes (1)

• Changes in relevant neurohumoral hormones in response to apelin infusion

  12 months

Study Arms (2)

Infusion of apelin

EXPERIMENTAL

Using forearm venous occlusion plethysmography apelin will be infused to cause reduction in forearm blood flow. Infusion of angiotensin II and noradrenaline will given and vasoconstriction will be assessed. Blood samples for the infused arm and contra-lateral arm will be taken at regular time points to assess local and systemic changes in relevant hormones.

Drug: Angiotensin II; Drug: Noradrenaline infusion

Sodium nitroprusside infusion

ACTIVE COMPARATOR

Using forearm venous occlusion plethysmography sodium nitroprusside will be infused to cause reduction in forearm blood flow. Infusion of angiotensin II and noradrenaline will given and vasoconstriction will be assessed. Blood samples for the infused arm and contra-lateral arm will be taken at regular time points to assess local and systemic changes in relevant hormones.

Drug: Angiotensin II; Drug: Noradrenaline infusion

Interventions

Angiotensin II DRUG

Infusion of up to 30picmol/ml angiotensin II will be infused and respondent vasoconstriction assessed.

Infusion of apelin; Sodium nitroprusside infusion

Noradrenaline infusion DRUG

Infusion of up to 480 picomol/ml of noradrenaline will be infused.

Infusion of apelin; Sodium nitroprusside infusion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years old
• Healthy volunteers

You may not qualify if:

• Lack of informed consent
• Age \< 18 years,
• Current involvement in other research studies,
• Systolic blood pressure \>190 mmHg or \<100 mmHg
• Malignant arrhythmias
• Renal or hepatic failure
• Haemodynamically significant aortic stenosis
• Severe or significant co morbidity
• Women of childbearing potential.
• Any regular medication
• Previous history of any cardiovascular disease

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc

Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Heart Diseases; Aneurysm

Interventions

Angiotensin II

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angiotensins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Gareth D Barnes, MBChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 10, 2010

Record last verified: 2009-05

Locations

GB (1)