Interaction of Apelin and Angiotensin in the Human Forearm Circulation

Heart Disease Clinical Trial

Official title:

Investigating the Interaction of Apelin and Angiotensin II Peripheral Resistance Vessels in Vivo in Man

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901745
• Other study ID #: FS/09/019/26905 - 1b
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: August 9, 2010
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2009
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases
• Vasodilation

Intervention

Drug:
• Angiotensin II
Infusion of up to 30picmol/ml angiotensin II will be infused and respondent vasoconstriction assessed.
• Noradrenaline infusion
Infusion of up to 480 picomol/ml of noradrenaline will be infused.

Locations

Country	Name	City	State
United Kingdom	Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in angiotensin II mediated vasoconstriction		12 months	No
Secondary	Changes in relevant neurohumoral hormones in response to apelin infusion		12 months	No