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Interaction of Apelin and Angiotensin in the Systemic Circulation

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ClinicalTrials.gov Identifier: NCT01049646
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
University of Edinburgh

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 improves that pumping ability of the heart and we wish to know if this action persists in the presence of increased levels of angiotensin II.


Condition or disease Intervention/treatment Phase
Renin Angiotensin System Drug: Angiotensin II Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Angiotensin II Drug: Angiotensin II
Infusion of a subpressor dose of angiotensin II will be give, this will be 0.5microG/min/kg. Thereafter thre ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.

Placebo Comparator: Saline infusion Drug: Saline
Infusion of saline. Thereafter three ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.




Primary Outcome Measures :
  1. Cardiac output [ Time Frame: 90 mins ]

Secondary Outcome Measures :
  1. Systemic haemodynamics [ Time Frame: 90mins ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049646


Locations
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United Kingdom
Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Gareth Barnes, University of Edinburgh
ClinicalTrials.gov Identifier: NCT01049646     History of Changes
Other Study ID Numbers: FS/09/019/26905 - 2
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: August 10, 2010
Last Verified: August 2010

Keywords provided by University of Edinburgh:
renin-angiotensin system
apelin
systemic haemodynamics

Additional relevant MeSH terms:
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Angiotensin II
Giapreza
Angiotensinogen
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action