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Interaction of Apelin and Angiotensin in the Systemic Circulation

This study has been completed.
Sponsor:
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01049646
First received: January 13, 2010
Last updated: August 9, 2010
Last verified: August 2010

January 13, 2010
August 9, 2010
January 2010
April 2010   (final data collection date for primary outcome measure)
Cardiac output [ Time Frame: 90 mins ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01049646 on ClinicalTrials.gov Archive Site
Systemic haemodynamics [ Time Frame: 90mins ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Interaction of Apelin and Angiotensin in the Systemic Circulation
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Renin Angiotensin System
  • 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.
  • 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.
  • Active Comparator: Angiotensin II
    Intervention: Drug: Angiotensin II
  • Placebo Comparator: Saline infusion
    Intervention: Drug: Saline
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
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01049646
FS/09/019/26905 - 2
No
Dr Gareth Barnes, University of Edinburgh
University of Edinburgh
Not Provided
Not Provided
University of Edinburgh
August 2010

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