ClinicalTrials.gg
CompletedNCT00901888Updated Aug 10, 2010

Interaction of Apelin and Angiotensin in the Human Forearm Circulation

An interventional study of Apelin infusion and Sodium nitroprusside infusion in Heart Disease and Vasodilation, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-10.

Sponsored by University of Edinburgh · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Heart Disease
  • Vasodilation

Keywords

  • Renin Angiotensin System
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In context

Heart Diseases

3,674 studies on the registry are indexed under Heart Diseases; 458 are open to participants now.

This study's planned enrollment of 12 is below the median of 100 across 1,785 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

University of Edinburgh is the lead sponsor of 403 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 18 years old

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (estimated)

Study arms

  • 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.

    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.

    Drug: Apelin infusion · Drug: Sodium nitroprusside infusion

Interventions

  • 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.

  • 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.

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What researchers measure

Primary outcomes

  1. Change in apelin mediated forearm blood flow

    Time frame: 12 months

Secondary outcomes

  1. Change in local and systemic plasma apelin concentration in response angiotensin II infusion

    Time frame: 12 months

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Study locations

1 site
  • Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
    Edinburgh, EH16 4SA, United Kingdom
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References and documents

Publications

  • 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. PubMed 23519586 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of May 2010 and a completion of May 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2009
First posted
May 14, 2009
Start
Apr 2009
Primary completionActual
May 2010
CompletionActual
May 2010
Last update
Aug 10, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00901888
Collaborators
NHS Lothian
First posted
May 14, 2009
Start date
Apr 2009
Primary completion
May 2010
Completion
May 2010
Last update
Aug 10, 2010

Study contacts

Gareth D Barnes, MBChB
principal investigator · University of Edinburgh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Apelin

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