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Interaction of Apelin and Angiotensin in the Human Forearm Circulation

This study has been completed.
Sponsor:
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00901745
First received: May 13, 2009
Last updated: August 9, 2010
Last verified: May 2009
History of Changes
  Purpose

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 has the ability to cause blood vessels to relax, increasing their diameter and hence blood flow down the blood vessel. The researchers wish to investigate the hypothesis that an infusion of apelin will reduce the effects of angiotensin II, which is know to reduce the diameter of blood vessels.


Condition Intervention
Heart Disease
Vasodilation
 Drug: Angiotensin II
Drug: Noradrenaline infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Investigating the Interaction of Apelin and Angiotensin II Peripheral Resistance Vessels in Vivo in Man

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Change in angiotensin II mediated vasoconstriction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in relevant neurohumoral hormones in response to apelin infusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infusion of apelin
Using forearm venous occlusion plethysmography apelin will be infused to cause reduction in forearm blood flow. Infusion of angiotensin II and noradrenaline will given and vasoconstriction 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: Angiotensin II
Infusion of up to 30picmol/ml angiotensin II will be infused and respondent vasoconstriction assessed.
Drug: Noradrenaline infusion
Infusion of up to 480 picomol/ml of noradrenaline will be infused.
Active Comparator: Sodium nitroprusside infusion
Using forearm venous occlusion plethysmography sodium nitroprusside will be infused to cause reduction in forearm blood flow. Infusion of angiotensin II and noradrenaline will given and vasoconstriction 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: Angiotensin II
Infusion of up to 30picmol/ml angiotensin II will be infused and respondent vasoconstriction assessed.
Drug: Noradrenaline infusion
Infusion of up to 480 picomol/ml of noradrenaline will be infused.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901745

Locations
United Kingdom
Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
Investigators
Principal Investigator: Gareth D Barnes, MBChB University of Edinburgh
  More Information

No publications provided

Responsible Party: Dr Gareth Barnes, University of Edinburgh
ClinicalTrials.gov Identifier: NCT00901745     History of Changes
Other Study ID Numbers: FS/09/019/26905 - 1b
Study First Received: May 13, 2009
Last Updated: August 9, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Renin angiotensin system
Apelin
Vasodilatation
Heart disease
Vascular biology

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Angiotensin II
Norepinephrine
Nitroprusside
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Nitric Oxide Donors
 Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013