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Completed

NCT Number: NCT01590108

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Hospital, Imperial College London, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(Pyr1)apelin-13

Drug

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

Saline

Drug

Saline

Primary outcomes

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

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Acronym: EXAP

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 2, 2012
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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