Interaction of Apelin and Angiotensin in the Systemic Circulation

Sponsor

University of Edinburgh (Other)

Overall Status

Completed

CT.gov ID

NCT01049646

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Renin Angiotensin System	Drug: Angiotensin II Drug: Saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Angiotensin II	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.
Placebo Comparator: Saline infusion	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.

Arm

Intervention/Treatment

Active Comparator: Angiotensin II

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.

Placebo Comparator: Saline infusion

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.

Outcome Measures

Primary Outcome Measures

Cardiac output [90 mins]

Secondary Outcome Measures

Systemic haemodynamics [90mins]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc	Edinburgh		United Kingdom	EH16 4SA

Sponsors and Collaborators

University of Edinburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01049646

Other Study ID Numbers:

FS/09/019/26905 - 2

First Posted:

Jan 14, 2010

Last Update Posted:

Aug 10, 2010

Last Verified:

Aug 1, 2010

Keywords provided by , ,

renin-angiotensin system

apelin

systemic haemodynamics

Additional relevant MeSH terms:

Angiotensin II

Giapreza

Angiotensinogen

Study Results

No Results Posted as of Aug 10, 2010