- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01049646
Interaction of Apelin and Angiotensin in the Systemic Circulation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Edinburgh, United Kingdom, EH16 4SA
- Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Infusion of saline.
Thereafter three ascending doses of apelin will be given, during which time cardiac output and systemic haemodynamics will be measured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiac output
Time Frame: 90 mins
|
90 mins
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Systemic haemodynamics
Time Frame: 90mins
|
90mins
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FS/09/019/26905 - 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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