Clinical trial NCT01590108: The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects
Official title: The Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Pulmonary Arterial Hypertension
Keywords: Idiopathic Pulmonary Arterial Hypertension
IPAH
Apelin
APJ receptor
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Apelin infusion on cardiopulmonary performance in healthy volunteers and patient with idiopathic pulmonary hypertension
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital, Imperial College London
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College NHS Trust
name: Luke Sebastian Howard, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College NHS trust
name: Gareth D Barnes, MBChB
role: STUDY_DIRECTOR
References: