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The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects (EXAP)

Primary Purpose

Idiopathic Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
(Pyr1)apelin-13
Saline
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Arterial Hypertension focused on measuring Idiopathic Pulmonary Arterial Hypertension, IPAH, Apelin, APJ receptor

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria for Control group:

  • Structurally normal heart by 2D Echocardiography
  • Pulmonary artery pressure < 25mmHg
  • Tricuspid velocity < 2.5ms-1

Inclusion Criteria for Treatment group:

  • 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.

Exclusion Criteria for ALL group:

  • 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

Sites / Locations

  • Hammersmith Hospital, Imperial College London
  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apelin

Control

Arm Description

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

Subject will take cardiopulmonary exercise testing with receive placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2012
Last Updated
April 12, 2019
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT01590108
Brief Title
The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects
Acronym
EXAP
Official Title
The Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Idiopathic pulmonary arterial hypertension remains an enigma for physician in both diagnosis and treatment. Existing biomarkers, tissue characteristics and definite treatment are restricted. There are many evidences suggested that Apelin-APJ system associated with Idiopathic Pulmonary Arterial Hypertension (IPAH). A comprehensive characterise circulating peptide levels and investigate any tissue gradients of apelin in patients with idiopathic pulmonary arterial hypertension and healthy volunteers might provide important information about pathophysiologic process and diagnostic marker. In addition, first time human study to assessment the effect of exogenous apelin infusion on exercise performance in healthy volunteers and patients with idiopathic pulmonary arterial hypertension is essential to confirm whether the relevance between animal models and clinical subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Arterial Hypertension
Keywords
Idiopathic Pulmonary Arterial Hypertension, IPAH, Apelin, APJ receptor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apelin
Arm Type
Experimental
Arm Description
Subject will perform cardiopulmonary exercise testing and receive (Pyr1)apelin-13 intravenously.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subject will take cardiopulmonary exercise testing with receive placebo
Intervention Type
Drug
Intervention Name(s)
(Pyr1)apelin-13
Intervention Description
(Pyr1)apelin-13 will be infused at 30 nanomol/min intravenously. This dose has been used in healthy volunteer and patients groups
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Effect of Apelin infusion on cardiopulmonary performance in healthy volunteers and patient with idiopathic pulmonary hypertension
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Control group: Structurally normal heart by 2D Echocardiography Pulmonary artery pressure < 25mmHg Tricuspid velocity < 2.5ms-1 Inclusion Criteria for Treatment group: 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. Exclusion Criteria for ALL group: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke Sebastian Howard, DPhil
Organizational Affiliation
Imperial College NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gareth D Barnes, MBChB
Organizational Affiliation
Imperial College NHS trust
Official's Role
Study Director
Facility Information:
Facility Name
Hammersmith Hospital, Imperial College London
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
w12 0NN
Country
United Kingdom

12. IPD Sharing Statement

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The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects

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