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Investigating the Inotropic Potential of Apelin (INO-apelin)

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ClinicalTrials.gov Identifier: NCT01179061
Recruitment Status : Unknown
Verified August 2010 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : August 10, 2010
Last Update Posted : January 14, 2011
Sponsor:
Information provided by:
University of Edinburgh

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Apelin Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigating the Inotropic Potential of Apelin in Healthy Volunteers and Patients With Chronic Stable Heart Failure
Study Start Date : August 2010
Estimated Primary Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Apelin infusion
6 hour infusion of apelin peptide into circulation
Drug: Apelin

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 Comparator: Placebo
Infusion of saline into systemic circulation
Drug: Placebo
As per apelin arm, however we will use a saline placebo infusion. All other aspects will remain the same.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179061


Contacts
Contact: Gareth D Barnes, MBChB 00447967621980 gareth.barnes@ed.ac.uk
Contact: Alan G Japp, MBChB alangjapp@hotmail.com

Locations
United Kingdom
Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Gareth D Barnes, MBChB    00447967621980    gareth.barnes@ed.ac.uk   
Sub-Investigator: Alan Japp, MBChB         
Sub-Investigator: Christian M Pedersen, MD         
Sub-Investigator: Nicholas A Boon, MBBChir,MD         
Sub-Investigator: David E Newby, BM, PhD, DM         
Sub-Investigator: Martin Denvir, MBChB, PhD         
Gareth Barnes Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Gareth D Barnes, MBChB    00447967621980    gareth.barnes@ed.ac.uk   
Contact: Alan G Japp, MBChB       alanglanjapp@hotmail.co.uk   
University of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Gareth D Barnes, MBChB       gareth.barnes@ed.ac.uk   
Principal Investigator: Gareth D Barnes, MBCHB         
Sponsors and Collaborators
University of Edinburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Gareth Barnes, University of Edinburgh
ClinicalTrials.gov Identifier: NCT01179061     History of Changes
Other Study ID Numbers: 10/S1101/18
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: January 14, 2011
Last Verified: August 2010

Keywords provided by University of Edinburgh:
Apelin
Heart failure
Pulmonary artery pressure
Inotropic
Diuretic

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases