NCT01457170

Brief Summary

The purpose of this study is to determine the effects of Apelin on the lung circulation. The investigators hypothesise that Apelin will relax the lung blood vessels and improve the pumping ability of the heart.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 15, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

October 20, 2011

Last Update Submit

July 12, 2013

Conditions

Pulmonary Arterial HypertensionHeart Failure

Keywords

Pulmonary HypertensionHeart FailureApelinHaemodynamicspulmonary vascular resistancecardiac output

Outcome Measures

Primary Outcomes (1)

  • Change in pulmonary vascular resistance

    We will measure the change in pulmonary vascular resistance after infusion of Apelin during right heart catheterisation

    5,10,15 and 30 minutes after start of infusion

Secondary Outcomes (2)

  • Change in systemic vascular resistance

    5,10,15 and 30 minutes after start of infusion

  • Change in Cardiac Output

    5,10,15 and 30 minutes after start of infusion

Study Arms (2)

Apelin/Saline

EXPERIMENTAL

Apelin infusion then crossover to Saline infusion

Drug: ApelinDrug: Saline (Placebo)

Saline/Apelin

EXPERIMENTAL

Saline infusion then crossover to Apelin infusion

Drug: Saline (Placebo)Drug: Apelin

Interventions

ApelinDRUG

During right heart catheterisation, Apelin will be infused at 30, 100 and 300 nanomol/min for 5 minutes. Apelin will then be infused at 300 nanomol/min for a further 15 minutes while the subject exercises using a supine ergometer.

Apelin/Saline
Saline (Placebo)DRUG

During right heart catheterisation, saline will be infused for 15 minutes while the subject rest and for a further 15 minutes while the subject exercises using a supine ergometer.

Apelin/Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pulmonary Arterial Hypertension which is Idiopathic, Heritable, associated with connective tissue disease or associated with drugs/toxins
  • mean pulmonary artery pressure \>/= 25mmHg
  • pulmonary capillary wedge pressure \< 15 mmHg
  • normal/reduced cardiac output
  • stable
  • WHO functional class II - IV

You may not qualify if:

  • significant left ventricular dysfunction
  • chronic lung disease (FEV1 \< 60% or abnormal CT)
  • chronic thromboembolic pulmonary hypertension
  • HEART FAILURE
  • stable on treatment for 3 months prior to study
  • NYHA grade II - IV
  • ejection fraction \<35%, left ventricular end-diastolic diameter \> 5.5 cm and/or shortening fraction \< 20%
  • Tricuspid regurgitant velocity \>/= 3.0 m/s
  • HEALTHY VOLUNTEERS
  • mean pulmonary artery pressure \< 25 mmHg
  • tricuspid regurgitant velocity \< 2.5 m/s
  • obstructive coronary artery disease
  • ALL SUBJECTS
  • bleeding diathesis
  • women of childbearing potential without pregnancy test
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal Infirmary Edinburgh

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

Golden Jubilee National Hospital

Glasgow, G81 4HX, United Kingdom

RECRUITING

Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

Related Publications (1)

  • Brash L, Barnes GD, Brewis MJ, Church AC, Gibbs SJ, Howard LSGE, Jayasekera G, Johnson MK, McGlinchey N, Onorato J, Simpson J, Stirrat C, Thomson S, Watson G, Wilkins MR, Xu C, Welsh DJ, Newby DE, Peacock AJ. Short-Term Hemodynamic Effects of Apelin in Patients With Pulmonary Arterial Hypertension. JACC Basic Transl Sci. 2018 Mar 28;3(2):176-186. doi: 10.1016/j.jacbts.2018.01.013. eCollection 2018 Apr.

    PMID: 29876530DERIVED

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHeart FailureHypertension, Pulmonary

Interventions

ApelinSodium Chloride

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHeart DiseasesCardiovascular DiseasesHypertensionVascular Diseases

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Andrew J Peacock, BSc MPhil MD

    National Health Service: Golden Jubilee National Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew J Peacock, BSc MPhil MD

CONTACT

+44 (0)141 951 5497apeacock@udcf.gla.ac.uk

Lauren Brash, MBChB

CONTACT

+44 (0)7738569980laurenbrash@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 21, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 15, 2013

Record last verified: 2013-07

Locations

GB(3)