The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects (EXAP)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Pulmonary Arterial Hypertension |
Drug: (Pyr1)apelin-13 Drug: Saline |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response. |
- Effect of Apelin infusion on cardiopulmonary performance in healthy volunteers and patient with idiopathic pulmonary hypertension [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment: | 12 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Apelin
Subject will perform cardiopulmonary exercise testing and receive (Pyr1)apelin-13 intravenously.
|
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
|
|
Placebo Comparator: Control
Subject will take cardiopulmonary exercise testing with receive placebo
|
Drug: Saline
Saline
|
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Male |
| Accepts 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
Contacts and Locations| Contact: Gareth D Barnes, MBChB | 07967 621 980 | g.barnes@imperial.ac.uk |
| United Kingdom | |
| Imperial College Healthcare NHS Trust | Recruiting |
| London, United Kingdom, w12 0NN | |
| Contact: Gareth D Barnes, MBChB g.barnes@imperial.ac.uk | |
| Contact: Akaphot Thongmee, MD akaphot.thongmee11@imperial.ac.uk | |
| Sub-Investigator: Gareth D Barnes, MBChB | |
| Principal Investigator: Luke Howard, PhD | |
| Sub-Investigator: Akaphot Thongmee, MD | |
| Hammersmith Hospital, Imperial College London | Not yet recruiting |
| London, United Kingdom, W12 0HS | |
| Contact: Gareth D Barnes, MBChB 07967 621 980 g.barnes@imperial.ac.uk | |
| Principal Investigator: | Luke Sebastian Howard, DPhil | Imperial College NHS Trust |
| Study Director: | Gareth D Barnes, MBChB | Imperial College NHS trust |
More Information
No publications provided
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01590108 History of Changes |
| Other Study ID Numbers: | 11/LO/2063 |
| Study First Received: | April 30, 2012 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee United Kingdom: Imperial College |
Keywords provided by Imperial College London:
|
Idiopathic Pulmonary Arterial Hypertension IPAH Apelin APJ receptor |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases |
Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013