Investigating the Inotropic Potential of Apelin (INO-apelin)

University of Edinburgh

Status: Completed

Conditions: Heart Failure

Treatments: Drug: Placebo; Drug: Apelin

Study type: Interventional

Funder types: Other

Identifiers

NCT01179061

10/S1101/18

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy volunteers:

>18yrs

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Apelin infusion

Experimental group

Description:

6 hour infusion of apelin peptide into circulation

Treatment:

Drug: Apelin

Placebo

Placebo Comparator group

Description:

Infusion of saline into systemic circulation

Treatment:

Drug: Placebo