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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Imperial College London.
Recruitment status was  Recruiting
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

April 30, 2012
May 1, 2012
March 2012
September 2014   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01590108 on ClinicalTrials.gov Archive Site
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Not Provided
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The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects
The Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response.

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Idiopathic Pulmonary Arterial Hypertension
  • 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
  • Drug: Saline
    Saline
  • Experimental: Apelin
    Subject will perform cardiopulmonary exercise testing and receive (Pyr1)apelin-13 intravenously.
    Intervention: Drug: (Pyr1)apelin-13
  • Placebo Comparator: Control
    Subject will take cardiopulmonary exercise testing with receive placebo
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Male
18 Years to 90 Years
Yes
Contact: Gareth D Barnes, MBChB 07967 621 980 g.barnes@imperial.ac.uk
United Kingdom
 
NCT01590108
11/LO/2063
No
Imperial College London
Imperial College London
Not Provided
Principal Investigator: Luke Sebastian Howard, DPhil Imperial College NHS Trust
Study Director: Gareth D Barnes, MBChB Imperial College NHS trust
Imperial College London
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP