Interaction of Apelin and Angiotensin in the Human Forearm Circulation

Sponsor
University of Edinburgh (Other)
Overall Status
Completed
CT.gov ID
NCT00901745
Collaborator
(none)
12
1
2
11
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Angiotensin II
  • Drug: Noradrenaline infusion
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Investigating the Interaction of Apelin and Angiotensin II Peripheral Resistance Vessels in Vivo in Man
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Drug: Noradrenaline infusion
Infusion of up to 480 picomol/ml of noradrenaline will be infused.

Active Comparator: 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.

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

Drug: Noradrenaline infusion
Infusion of up to 480 picomol/ml of noradrenaline will be infused.

Outcome Measures

Primary Outcome Measures

  1. Change in angiotensin II mediated vasoconstriction [12 months]

Secondary Outcome Measures

  1. Changes in relevant neurohumoral hormones in response to apelin infusion [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc Edinburgh United Kingdom EH16 4SA

Sponsors and Collaborators

  • University of Edinburgh

Investigators

  • Principal Investigator: Gareth D Barnes, MBChB, University of Edinburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00901745
Other Study ID Numbers:
  • FS/09/019/26905 - 1b
First Posted:
May 14, 2009
Last Update Posted:
Aug 10, 2010
Last Verified:
May 1, 2009

Study Results

No Results Posted as of Aug 10, 2010