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Completed

NCT Number: NCT00901719

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

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.

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Key information

Conditions

Heart Disease Aneurysm Cardiovascular Diseases Heart Diseases Heart Failure Vascular Diseases Vasodilatation

Age range

18 month–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc

Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18yr

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

Treatment and study plan

Apelin

Drug

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

Acetylcholine

Drug

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

Sodium Nitroprusside

Drug

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

Systemic apelin infusion

Drug

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.

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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • NHS Lothian

Registry information

Official study title

Investigating the Interaction of Apelin and Systemic Angiotensin II Peripheral Resistance Vessels and Systemic Haemodynamics in Vivo in Man

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 14, 2009
Registry last updated
Aug 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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