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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01590108 |
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Date of registration:
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30/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects
EXAP |
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Scientific title:
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The Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response. |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01590108 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Gareth D Barnes, MBChB |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imperial College NHS trust |
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Name:
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Luke Sebastian Howard, DPhil |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imperial College NHS Trust |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: (Pyr1)apelin-13
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Drug: Saline
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Primary Outcome(s)
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Effect of Apelin infusion on cardiopulmonary performance in healthy volunteers and patient with idiopathic pulmonary hypertension
[Time Frame: 6 months]
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Secondary ID(s)
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11/LO/2063
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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