Interaction of Apelin and Angiotensin in the Systemic Circulation

Renin Angiotensin System Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049646
• Other study ID #: FS/09/019/26905 - 2
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: August 9, 2010
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: August 2010
• 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 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.

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: Male
• 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, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renin Angiotensin System

Intervention

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

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	Cardiac output		90 mins	No
Secondary	Systemic haemodynamics		90mins	No