Interaction of Apelin and Angiotensin in the Human Forearm Circulation

This study has been completed.
Sponsor:
Collaborator:
NHS Lothian
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00901888
First received: May 8, 2009
Last updated: August 9, 2010
Last verified: August 2010

May 8, 2009
August 9, 2010
April 2009
May 2010   (final data collection date for primary outcome measure)
Change in apelin mediated forearm blood flow [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00901888 on ClinicalTrials.gov Archive Site
Change in local and systemic plasma apelin concentration in response angiotensin II infusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Interaction of Apelin and Angiotensin in the Human Forearm Circulation
Investigating the Interaction of Apelin and Angiotensin II Peripheral Resistance Vessels in Vivo in Man

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Heart Disease
  • Vasodilation
  • 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.
  • Drug: 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.
  • Experimental: Angiotensin II infusion
    Using forearm venous occlusion plethysmography angiotensin II will be infused to cause reduction in forearm blood flow. Infusion of apelin and sodium nitroprusside will given and vasodilatation 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.
    Interventions:
    • Drug: Apelin infusion
    • Drug: Sodium nitroprusside infusion
  • Active Comparator: Noradrenaline
    Using forearm venous occlusion plethysmography noradrenaline will be infused to cause reduction in forearm blood flow. Infusion of apelin and sodium nitroprusside will given and vasodilatation 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.
    Interventions:
    • Drug: Apelin infusion
    • Drug: Sodium nitroprusside infusion
Barnes GD, Alam S, Carter G, Pedersen CM, Lee KM, Hubbard TJ, Veitch S, Jeong H, White A, Cruden NL, Huson L, Japp AG, Newby DE. Sustained cardiovascular actions of APJ agonism during renin-angiotensin system activation and in patients with heart failure. Circ Heart Fail. 2013 May;6(3):482-91. doi: 10.1161/CIRCHEARTFAILURE.111.000077. Epub 2013 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00901888
FS/09/019/26905 - 1a
No
Dr Gareth Barnes, Research Fellow, University of Edinburgh
University of Edinburgh
NHS Lothian
Principal Investigator: Gareth D Barnes, MBChB University of Edinburgh
University of Edinburgh
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP