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

This study is currently recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2012

Last Updated Date

May 1, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01590108 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Idiopathic Pulmonary Arterial Hypertension

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2014

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Gareth D Barnes, MBChB

07967 621 980

g.barnes@imperial.ac.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01590108

Other Study ID Numbers ^ICMJE

11/LO/2063

Has Data Monitoring Committee

Responsible Party

Imperial College London

Study Sponsor ^ICMJE

Imperial College London

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Luke Sebastian Howard, DPhil	Imperial College NHS Trust
Study Director:	Gareth D Barnes, MBChB	Imperial College NHS trust

Information Provided By

Imperial College London

Verification Date

April 2012

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

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