The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects (EXAP)
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|ClinicalTrials.gov Identifier: NCT01590108|
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : February 17, 2016
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 or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Arterial Hypertension||Drug: (Pyr1)apelin-13 Drug: Saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response.|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Subject will perform cardiopulmonary exercise testing and receive (Pyr1)apelin-13 intravenously.
(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
- Effect of Apelin infusion on cardiopulmonary performance in healthy volunteers and patient with idiopathic pulmonary hypertension [ Time Frame: 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.
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): NCT01590108
|Hammersmith Hospital, Imperial College London|
|London, United Kingdom, W12 0HS|
|Imperial College Healthcare NHS Trust|
|London, United Kingdom, w12 0NN|
|Principal Investigator:||Luke Sebastian Howard, DPhil||Imperial College NHS Trust|
|Study Director:||Gareth D Barnes, MBChB||Imperial College NHS trust|