CClinicalTrials.gg
CompletedNCT00901719Updated Aug 10, 2010

Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation

An interventional study of Apelin and Acetylcholine in Heart Disease, Heart Failure and Vasodilatation, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 18 Months 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 Months 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.

Two of the main actions of apelin are to increase the pumping ability of the heart and cause blood vessels to relax. The investigators wish to assess if these actions are altered in the setting of normal renin-angiotensin activation and increased renin-angiotensin activity.

02

Conditions studied

  • Heart Disease
  • Heart Failure
  • Vasodilatation

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Keywords

  • Renin angiotensin system
  • Apelin
  • Cardiac output
  • Vasodilatation
03

In context

Heart Diseases

3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 12 is below the median of 100 across 1,779 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • >18yr

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
05

Study design

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

Study arms

  • Experimental
    Sodium depletion

    Subjects will be randomised to normal diet or sodium depleted diet. The sodium depletion protocol comprises of a single oral dose of 40 mg of furosemide followed by an out-patient diet containing \>2000 kcal of energy, \>60 g of protein, \<12 mmol of sodium and \<70 mmol of potassium per day for 3 days prior to study. This diet is know to increase the activity of the renin-angiotensin system.

    Drug: Apelin · Drug: Acetylcholine · Drug: Sodium nitroprusside · Drug: Systemic apelin infusion

  • Placebo comparator
    Normal diet

    Subjects will be randomised to a normal diet, with no restriction on sodium intake during the three days prior to the study.

    Drug: Apelin · Drug: Acetylcholine · Drug: Sodium nitroprusside · Drug: Systemic apelin infusion

Interventions

  • DrugApelin

    Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial apelin infusions at 0.3, 1.0 and 3.0 nanomol/ml.

  • DrugAcetylcholine

    Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 5, 10 and 20 microg/min

  • DrugSodium nitroprusside

    Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 1, 2 and 4 microg/min

  • DrugSystemic apelin infusion

    Following plethysmography patients will receive systemic infusion of (Pry)Apelin-13 (30, 100 and 300 nmol/min) for 5 mins cardiac output, blood pressure, heart rate and systemic vascular resistance will be measured at 5-min intervals.

06

What researchers measure

Primary outcomes

  1. Change in cardiac output

    Time frame: 12 months

  2. Change in apelin mediated vasodilatation

    Time frame: 12 months

Secondary outcomes

  1. Change in systemic haemodynamics

    Time frame: 12 months

  2. Change in relevant neurohumoral hormones

    Time frame: 12 months

07

Study locations

1 site
  • Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
    Edinburgh, EH16 4SA, United Kingdom
08

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 ↗
09

Updates

Tracking since Sep 25, 2026
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 ↗
10

Registry details

Key details

Study ID
NCT00901719
Lead sponsor
University of Edinburgh
Collaborators
NHS Lothian, British Heart Foundation
First posted
May 14, 2009
Start date
Apr 2010
Primary completion
May 2010
Completion
May 2010
Last update
Aug 10, 2010

Oversight

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

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This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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