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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901719
• Other study ID #: FS/09/019/26905 - 3
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: August 9, 2010
• Start date: April 2010
• Est. completion date: May 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Heart Disease
• Heart Failure
• Vasodilatation

Intervention

Drug:
• Apelin
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
Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 5, 10 and 20 microg/min
• Sodium nitroprusside
Using the technique of venous occlusive plethysmography subjects will receive three intrabrachial acetylcholine infusions at 1, 2 and 4 microg/min
• Systemic apelin infusion
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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiac output		12 months	No
Primary	Change in apelin mediated vasodilatation		12 months	No
Secondary	Change in systemic haemodynamics		12 months	No
Secondary	Change in relevant neurohumoral hormones		12 months	No