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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01590108

Acronym

EXAP

Enrollment

Registered

2012-05-02

Start date

2012-03-31

Completion date

2014-09-30

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Arterial Hypertension

Keywords

Idiopathic Pulmonary Arterial Hypertension, IPAH, Apelin, APJ receptor

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.

Interventions

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

DRUGSaline

Saline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Effect of Apelin infusion on cardiopulmonary performance in healthy volunteers and patient with idiopathic pulmonary hypertension	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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026