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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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16 December 2017 |
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Main ID: |
NCT03236818 |
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Date of registration:
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18/03/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Goal Oriented Strategy to Preserve Ejection Fraction Trial
GOSPEL |
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Scientific title:
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Raising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction Trial |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03236818 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Anton Vonk Noordegraaf, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VU University Medical Center, department of pulmonary diseases |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Idiopathic or heritable pulmonary arterial hypertension
- New York Heart Association (NYHA) functional class II or III
Exclusion Criteria:
- Other causes of pulmonary arterial hypertension (i.e. collagen vascular disease,
congenital heart disease, chrono-thromboembolic pulmonary hypertension, pulmonary
venous hypertension, left heart failure, hypoxemic lung disease)
- Pulmonary arterial hypertension targeted therapies before study inclusion
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)
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Primary Outcome(s)
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Change in right ventricular ejection fraction
[Time Frame: 4,12, 24 months of follow-up]
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Secondary Outcome(s)
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pulmonary vascular resistance
[Time Frame: 4,12, 24 months of follow-up]
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Cardiac output in L/min (Thermodilution method)
[Time Frame: 4,8, 12, 24 months of follow-up]
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Exercise capacity
[Time Frame: 4,8, 12, 24 months of follow-up]
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mPAP
[Time Frame: 4,12, 24 months of follow-up]
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New York Heart Association functional class
[Time Frame: 4,8, 12, 24 months of follow-up]
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Secondary ID(s)
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NL41878.029.13
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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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