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: NCT00901888
• Other study ID #: FS/09/019/26905 - 1a
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: August 9, 2010
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2010
• 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.

Angiotensin has a powerful ability to cause blood vessels constrict and reduces their diameter. One of the actions of apelin is to cause blood vessels to relax and the investigators specifically wish test the hypothesis that apelin will cause blood vessels constricted by angiotensin II to relax.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• > 18 years old

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
• Vasodilation

Intervention

Drug:
• Apelin infusion
Infusion of up to 10picmol/min will be administered intra-arterially to induce vasoconstriction. Thereafter infusions of apelin (0.1, 1.0, 3.0nmol/min) will be given for 6mins each. During the same study, sodium nitroprusside will given (1.0, 2.0, 4.0 microg/min) for 6mins.
• Sodium nitroprusside infusion
Infusion of up to 150-600picmol/min will be administered intra-arterially to induce vasoconstriction. Thereafter infusions of apelin (0.1, 1.0, 3.0nmol/min) will be given for 6mins each. During the same study, sodium nitroprusside will given (1.0, 2.0, 4.0 microg/min) for 6mins.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in apelin mediated forearm blood flow		12 months	No
Secondary	Change in local and systemic plasma apelin concentration in response angiotensin II infusion		12 months	No