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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00901745
Other study ID # FS/09/019/26905 - 1b
Secondary ID
Status Completed
Phase N/A
First received May 13, 2009
Last updated August 9, 2010
Start date May 2009
Est. completion date April 2010

Study information

Verified date May 2009
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Angiotensin II
Infusion of up to 30picmol/ml angiotensin II will be infused and respondent vasoconstriction assessed.
Noradrenaline infusion
Infusion of up to 480 picomol/ml of noradrenaline will be infused.

Locations

Country Name City State
United Kingdom Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc Edinburgh

Sponsors (1)

Lead Sponsor Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in angiotensin II mediated vasoconstriction 12 months No
Secondary Changes in relevant neurohumoral hormones in response to apelin infusion 12 months No
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