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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01590108
First received: April 30, 2012
Last updated: May 1, 2012
Last verified: April 2012
  Purpose

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.

Condition Intervention Phase
Idiopathic Pulmonary Arterial Hypertension
Drug: (Pyr1)apelin-13
Drug: Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Effect of Apelin infusion on cardiopulmonary performance in healthy volunteers and patient with idiopathic pulmonary hypertension [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 12
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apelin
Subject will perform cardiopulmonary exercise testing and receive (Pyr1)apelin-13 intravenously.
Drug: (Pyr1)apelin-13
(Pyr1)apelin-13 will be infused at 30 nanomol/min intravenously. This dose has been used in healthy volunteer and patients groups
Placebo Comparator: Control
Subject will take cardiopulmonary exercise testing with receive placebo
Drug: Saline
Saline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590108

Contacts
Contact: Gareth D Barnes, MBChB 07967 621 980 g.barnes@imperial.ac.uk

Locations
United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, w12 0NN
Contact: Gareth D Barnes, MBChB       g.barnes@imperial.ac.uk   
Contact: Akaphot Thongmee, MD       akaphot.thongmee11@imperial.ac.uk   
Sub-Investigator: Gareth D Barnes, MBChB         
Principal Investigator: Luke Howard, PhD         
Sub-Investigator: Akaphot Thongmee, MD         
Hammersmith Hospital, Imperial College London Not yet recruiting
London, United Kingdom, W12 0HS

Contact: Gareth D Barnes, MBChB    07967 621 980    g.barnes@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Luke Sebastian Howard, DPhil Imperial College NHS Trust
Study Director: Gareth D Barnes, MBChB Imperial College NHS trust
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01590108     History of Changes
Other Study ID Numbers: 11/LO/2063
Study First Received: April 30, 2012
Last Updated: May 1, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United Kingdom: Imperial College

Keywords provided by Imperial College London:
Idiopathic Pulmonary Arterial Hypertension
IPAH
Apelin
APJ receptor

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014