Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures
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|ClinicalTrials.gov Identifier: NCT02129309|
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : June 25, 2015
The investigators are interested in studying how Pulmonary Hypertension occurs. A substance called 'apelin', that naturally occurs in the body has been shown to have an important role in heart disease. Previous studies have shown that it can make blood vessels get wider, and help blood flow around the body and thus improve the way the heart and lungs work.
The investigators are looking to recruit both healthy and COPD pulmonary hypertension patients to study 3 types of apelin. The purpose of this study is to help the investigators understand how Pulmonary Hypertension occurs which may will help with the development of future treatments.
|Condition or disease||Intervention/treatment||Phase|
|COPD Pulmonary Hypertension||Procedure: Forearm plethysmography Procedure: Haemodynamic studies||Not Applicable|
The purpose of this study:
To investigate the physiological role of apelin in the cardiovascular system in patients with COPD with raised pulmonary artery pressures.
Study Aim and hypotheses:
The primary objective is to test the above hypotheses using forearm blood flow and systemic infusions of apelin peptides.
- Apelin agonists are vasodilators in human resistance vessels and this effect will be altered in patients with pulmonary hypertension.
- Apelin peptides improve right ventricular and pulmonary haemodynamics in patients with elevated pulmonary artery pressures.
Study 1a - A validation dose study of 3 apelin agonists performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 1b- A validation dose study of apelin receptor antagonist, in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 2a - To define the haemodynamic response to apelin agonists in healthy volunteers and evaluate the response.
Study 2b - To investigate the haemodynamic response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures.|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Systemic Apelin infusion
Study 2a - Haemodynamic studies to investigate the response to systemic infusions of 3 apelin agonists in healthy volunteers
Study 2b - Haemodynamic studies to investigate the response to 3 apelin agonists in COPD patients with elevated pulmonary artery pressures
Procedure: Haemodynamic studies
Dose response study
Experimental: Apelin infusion - forearm
Study 1a - A validation dose study of 3 apelin agonists using forearm plethysmography to evaluate changes in forearm blood flow: performed in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Study 1b- A validation dose study of apelin receptor antagonist using forearm plethysmography to evaluate changes in forearm blood flow, in healthy volunteers and COPD patients with elevated pulmonary artery pressures.
Procedure: Forearm plethysmography
Dose response study
- Percentage change in forearm blood flow in the infused arm. Forearm blood flow ratio in each arm, blood pressure and heart rate will also be reported. [ Time Frame: 12 months ]
- Cardiac output and stroke volume, pulmonary vascular resistance, mean arterial pressure and heart rate. [ Time Frame: 12 months ]
- Exploratory endpoints in Study 2 are systolic and diastolic blood pressure. [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129309
|Vascular Research Unit, Clinical Pharmacology Unit, ACCI, Level 3, Addenbrooke's Hospital, Hills Road|
|Cambridge, United Kingdom, CB2 0QQ|
|Principal Investigator:||Dr. Joseph Cheriyan, MD||Cambridge University Hospitals NHS Foundation Trust|