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Completed

NCT Number: NCT01179061

Investigating the Inotropic Potential of Apelin

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc, Edinburgh, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apelin

Drug

Cardiac index will be assess in patients through the 6hr infusion, using thoracic cardiac bioimpedance. Prior to starting the infusion there will be a 30 minute run in period to achieve a stable cardiac index. Thereafter the infusion will be started, with cardiac index assess every five minutes during the first hour. For each subsequent hour participants will be free to mobilise for the thirty minute periods, with cardiac index and systemic haemodynmics assess for the following thirty minutes.

Additionally during the first hour pulmonary artery pressure will be estimated from pulmonary artery pressures assessed with echocardiography. This will be assessed at baseline with four further measurements during the first hour of infusion.

Participants will be asked to void prior to the study starting, thereafter all urine will be collected during the course of the study. Relevant biochemical/humoral factors will be assessed in the urine.

Placebo

Drug

As per apelin arm, however we will use a saline placebo infusion. All other aspects will remain the same.

Primary outcomes

  1. 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

  1. Urine volume

    Time frame: 6 hours

    All urine will be collected during the studya and we will assess volume and relevant biochemical/humoral factors

  2. Pulmonary artery pressure

    Time frame: 1 hour

    Using echocardiography we will estimate the pulmaonary artery pressure from pulmonary velocity and assess any change during the first hour of study.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Investigating the Inotropic Potential of Apelin in Healthy Volunteers and Patients With Chronic Stable Heart Failure

Acronym: INO-apelin

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2010
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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