Investigating the Inotropic Potential of Apelin (INO-apelin)
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Heart Failure |
Drug: Apelin Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Investigating the Inotropic Potential of Apelin in Healthy Volunteers and Patients With Chronic Stable Heart Failure |
- cardiac output [ Time Frame: 6 hours ] [ Designated as safety issue: No ]We will assess, using thoracic bioimpedance cardiography, the change in cardiac output in response to apelin infusion
- Urine volume [ Time Frame: 6 hours ] [ Designated as safety issue: No ]All urine will be collected during the studya and we will assess volume and relevant biochemical/humoral factors
- Pulmonary artery pressure [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Using echocardiography we will estimate the pulmaonary artery pressure from pulmonary velocity and assess any change during the first hour of study.
| Estimated Enrollment: | 24 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Gareth D Barnes, MBChB | 00447967621980 | gareth.barnes@ed.ac.uk |
| Contact: Alan G Japp, MBChB | alangjapp@hotmail.com |
| United Kingdom | |
| 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 | |
| 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 | |
| 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 | |
More Information
No publications provided
| Responsible Party: | Dr Gareth Barnes, University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT01179061 History of Changes |
| Other Study ID Numbers: | 10/S1101/18 |
| Study First Received: | August 9, 2010 |
| Last Updated: | January 13, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: National Health Service |
Keywords provided by University of Edinburgh:
|
Apelin Heart failure Pulmonary artery pressure Inotropic Diuretic |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013