Interaction of Apelin and Angiotensin in the Human Forearm Circulation

NCT ID: NCT00901745

Last Updated: 2010-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Infusion of apelin

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.

Group Type: EXPERIMENTAL

Angiotensin II

Intervention Type: DRUG

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

Noradrenaline infusion

Intervention Type: DRUG

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

Sodium nitroprusside infusion

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.

Group Type: ACTIVE_COMPARATOR

Angiotensin II

Intervention Type: DRUG

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

Noradrenaline infusion

Intervention Type: DRUG

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

Interventions

Angiotensin II

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

Intervention Type: DRUG

Noradrenaline infusion

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• > 18 years old
• Healthy volunteers

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

University of Edinburgh

Principal Investigators

Gareth D Barnes, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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

Edinburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

FS/09/019/26905 - 1b

Identifier Type: -

Identifier Source: org_study_id