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

Idiopathic Pulmonary Arterial Hypertension Clinical Trial

— EXAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590108
• Other study ID #: 11/LO/2063
• Status: Completed
• Phase: Phase 1
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Idiopathic Pulmonary Arterial Hypertension

Intervention

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
• Saline
Saline

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital, Imperial College London	London
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months