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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Idiopathic Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: (Pyr1)apelin-13
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apelin<br>Subject will perform cardiopulmonary exercise testing and receive (Pyr1)apelin-13 intravenously. | Drug: (Pyr1)apelin-13<br>* (Pyr1)apelin-13 will be infused at 30 nanomol/min intravenously. This dose has been used in healthy volunteer and patients groups<br>|
| Placebo Comparator: Control<br>Subject will take cardiopulmonary exercise testing with receive placebo | Drug: Saline<br>* Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Pulmonary Arterial Hypertension, APJ receptor, IPAH, Apelin