Investigating the Inotropic Potential of Apelin in Healthy Volunteers and Patients With Chronic Stable Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Edinburgh
- Enrollment
- 24
- Locations
- 3
- Primary Endpoint
- cardiac output
Study Overview
Brief Summary
The apelin-APJ system is a recently discover hormone system that has several important actions in the cardiovascular system. Apelin causes the heart pump with more force and also causes blood vessels to relax. Studies to date show that people with reduced pumping function of the heart have lower levels of apelin in the bloodstream compared to people with normal heart function. We have previously given apelin to healthy volunteers and people with reduced pumping function and this increases the heart's contraction. However, this has only been assessed over a short time period, around fifteen minutes, and we now want to know if this effect is seen over a longer period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers:
- •Heart failure patients;
- •New York Heart Failure class II-IV
- •Ejection fractional <35% or fractional shortening <20% within previous 6months.
Exclusion Criteria
- •All subjects,
- •Females of child bearing age not on adequate contraception
- •Lack of informed consent
- •Age <18yrs
- •Current involvement in any other research study
- •Systolic BP >190 or <100
- •Malignant arrhythmias
- •Renal or hepatic failure
- •Haemodynamically significant aortic stenosis
- •Severe or significant co-morbidity
- •Pacemakers
- •Healthy volunteers
- •Any regular medication
- •Previous history of any cardiovascular disease
Arms & Interventions
Apelin infusion
6 hour infusion of apelin peptide into circulation
Intervention: Apelin (Drug)
Placebo
Infusion of saline into systemic circulation
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
cardiac output
Time Frame: 6 hours
We will assess, using thoracic bioimpedance cardiography, the change in cardiac output in response to apelin infusion
Secondary Outcomes
- Urine volume(6 hours)
- Pulmonary artery pressure(1 hour)