NCT01590108

Brief Summary

The purpose of this study is to

  • Determine blood peptide levels and investigate any tissue gradients of apelin in patients with idiopathic pulmonary arterial hypertension and healthy volunteers.
  • Evaluate the effect of exogenous apelin infusion on exercise performance in healthy volunteers and patients with idiopathic pulmonary arterial hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2012

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

April 30, 2012

Last Update Submit

April 12, 2019

Conditions

Idiopathic Pulmonary Arterial Hypertension

Keywords

Idiopathic Pulmonary Arterial HypertensionIPAHApelinAPJ receptor

Outcome Measures

Primary Outcomes (1)

  • Effect of Apelin infusion on cardiopulmonary performance in healthy volunteers and patient with idiopathic pulmonary hypertension

    Characterise circulating peptide levels and investigate any tissue gradients of apelin in patients with idiopathic pulmonary arterial hypertension and healthy volunteers. Assess the effect of exogenous apelin infusion on exercise performance in healthy volunteers and patients with idiopathic pulmonary arterial hypertension.

    6 months

Study Arms (2)

Apelin

EXPERIMENTAL

Subject will perform cardiopulmonary exercise testing and receive (Pyr1)apelin-13 intravenously.

Drug: (Pyr1)apelin-13

Control

PLACEBO COMPARATOR

Subject will take cardiopulmonary exercise testing with receive placebo

Drug: Saline

Interventions

(Pyr1)apelin-13DRUG

(Pyr1)apelin-13 will be infused at 30 nanomol/min intravenously. This dose has been used in healthy volunteer and patients groups

Apelin
SalineDRUG

Saline

Control

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Structurally normal heart by 2D Echocardiography
  • Pulmonary artery pressure \< 25mmHg
  • Tricuspid velocity \< 2.5ms-1
  • Clinical diagnosis of Pulmonary arterial hypertension that is idiopathic, associated with anorexigens associated with connective tissue disease or familial
  • Able to give informed consent
  • Mean pulmonary artery pressure \> 25mmHg, pulmonary capillary wedge pressure \< 15mmHg, with normal or reduced cardiac output.

You may not qualify if:

  • Bleeding diathesis (PT \> 14 sec to aPTT \> 40 sec)
  • Pregnancy, or women of child bearing potential not on adequate contraception
  • Renal or hepatic failure
  • Severe valvular heart disease
  • Left ventricular dysfunction (LVEF \< 40)
  • Chronic lung disease
  • Malignant arrhythmias
  • Chronic thromboembolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hammersmith Hospital, Imperial College London

London, W12 0HS, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, w12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Interventions

apelin 13, Pyr(1)-Sodium Chloride

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Luke Sebastian Howard, DPhil

    Imperial College NHS Trust

    PRINCIPAL INVESTIGATOR

  • Gareth D Barnes, MBChB

    Imperial College NHS trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 2, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

GB(2)