Investigating the Inotropic Potential of Apelin

NCT01179061 | Completed

• 1 other identifier: 10/S1101/18
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Failure

Keywords

Apelin; Heart failure; Pulmonary artery pressure; Inotropic; Diuretic

Outcome Measures

Primary Outcomes (1)

• cardiac output

  We will assess, using thoracic bioimpedance cardiography, the change in cardiac output in response to apelin infusion

  6 hours

Secondary Outcomes (2)

• Urine volume

  6 hours

• Pulmonary artery pressure

  1 hour

Study Arms (2)

Apelin infusion

EXPERIMENTAL

6 hour infusion of apelin peptide into circulation

Drug: Apelin

Placebo

PLACEBO COMPARATOR

Infusion of saline into systemic circulation

Drug: Placebo

Interventions

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.

Apelin infusion

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers:
• \>18yrs
• Heart failure patients;
• New York Heart Failure class II-IV
• Ejection fractional \<35% or fractional shortening \<20% within previous 6months.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (3)

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

Edinburgh, EH16 4SA, United Kingdom

Location

Gareth Barnes

Edinburgh, EH16 4SA, United Kingdom

Location

University of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Barnes GD, Alam S, Carter G, Pedersen CM, Lee KM, Hubbard TJ, Veitch S, Jeong H, White A, Cruden NL, Huson L, Japp AG, Newby DE. Sustained cardiovascular actions of APJ agonism during renin-angiotensin system activation and in patients with heart failure. Circ Heart Fail. 2013 May;6(3):482-91. doi: 10.1161/CIRCHEARTFAILURE.111.000077. Epub 2013 Mar 21.

  PMID: 23519586 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Apelin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 10, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 9, 2024

Record last verified: 2010-08

Locations

GB (3)