Cardiovascular Effects of Apelin In Healthy Volunteers
1 other identifier
interventional
14
1 country
2
Brief Summary
Apelin is an endogenous peptide with physiological actions in the cardiovascular system. Apelin can modulate vasomotor tone and is a potent endogenous inotrope. In a series of clinical studies, we have shown that apelin causes peripheral and coronary vasodilatation and increased cardiac contractility. We wish to study and compare the cardiovascular effects of subcutaneous versus intravenous apelin. We specifically wish to determine how different methods of apelin administration affect cardiac output and peripheral vascular resistance in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1 healthy
Started Nov 2014
Shorter than P25 for early_phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 1, 2015
May 1, 2015
6 months
October 1, 2014
May 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in cardiac output between different methods of apelin administration.
Difference in cardiac output between different treatment arms. This will be assessed by recording cardiac index in L/min/m2 and Stroke volume index mL/min/m2
10 hours
Change in blood pressure between different methods of apelin administration.
Difference in blood pressure between different treatment arms assessed by measuring mean blood pressure in mmHg. Mean arterial pressure (MAP) will be calculated as diastolic blood pressure plus a third of the pulse pressure
10 hours
Secondary Outcomes (1)
Change in apelin concentrations between the different methods of administration
24 hours
Study Arms (3)
Protocol 1. Apelin 1mg doses
EXPERIMENTAL5 Healthy volunteers
Protocol 2. Apelin 5mg doses
EXPERIMENTAL5 Healthy volunteers
Protocol 3. Apelin 10mg single dose
EXPERIMENTAL5 Healthy volunteers
Interventions
single subcutaneous injection of Apelin 1mg subcutaneous
15 minute intravenous bolus of Apelin 1mg intravenous
single subcutaneous injection of Apelin 5mg subcutaneous
15 minute intravenous infusion of Apelin 5mg intravenous
24 hour continuous subcutaneous infusion of Apelin 10 mg subcutaneous
Eligibility Criteria
You may qualify if:
- Healthy males or females \>18 years old
- Willing and able to complete an informed consent form
You may not qualify if:
- Unable to give informed consent
- Pregnant or lactating at screening
- Use of any investigation product or device within 30 days prior to study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- NHS Lothiancollaborator
Study Sites (2)
Clinical Research Facility University of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Wellcome Trust Clinical Research Facility. Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Newby
British Heart Foundation
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2014
First Posted
October 8, 2014
Study Start
November 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 1, 2015
Record last verified: 2015-05