Interaction of Apelin and Angiotensin in the Systemic Circulation

NCT ID: NCT01049646

Last Updated: 2010-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renin Angiotensin System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Angiotensin II

Group Type ACTIVE_COMPARATOR

Angiotensin II

Intervention Type DRUG

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.

Saline infusion

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Infusion of saline. Thereafter three ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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University of Edinburgh

Locations

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

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 23519586 (View on PubMed)

Other Identifiers

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FS/09/019/26905 - 2

Identifier Type: -

Identifier Source: org_study_id

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