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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-09-30

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.

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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.

Conditions

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Idiopathic Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Apelin

Subject will perform cardiopulmonary exercise testing and receive (Pyr1)apelin-13 intravenously.

Group Type EXPERIMENTAL

(Pyr1)apelin-13

Intervention Type DRUG

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

Control

Subject will take cardiopulmonary exercise testing with receive placebo

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Saline

Interventions

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(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

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Structurally normal heart by 2D Echocardiography
* Pulmonary artery pressure \< 25mmHg
* Tricuspid velocity \< 2.5ms-1

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes