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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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11 April 2016 |
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Main ID: |
NCT02309463 |
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Date of registration:
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22/10/2014 |
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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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Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance & 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension
LONGACT |
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Scientific title:
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A Prospective Multicenter Study to Assess the Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance and 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension Newly Initiating Endothelin Receptor Antagonist Therapy |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02309463 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female patients with right heart catheter (RHC)-confirmed PAH (WHO PH group
I)
- Age =18 year
- Not receiving ERA therapy in the 30 days prior to the enrolment visit
- Signed patient informed consent form
Exclusion Criteria:
- Patient with conditions that prevent compliance with the protocol or to adhere to
therapy and use of the device
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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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: Endothelin receptor antagonist therapy
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Primary Outcome(s)
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Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment
[Time Frame: Baseline to Week 54]
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Change of physical activity measured with an electronic activity tracker and 6MWD in PAH patients newly initiating ERA therapy between visit 0 and end of observation
[Time Frame: baseline to week 54]
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Secondary Outcome(s)
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Number of hospitalization due to PAH (min. overnight)
[Time Frame: Baseline to Week 54]
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WHO Functional Class
[Time Frame: Baseline to Week 54]
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Quality of Life
[Time Frame: Baseline to Week 54]
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Echocardiography parameters
[Time Frame: Baseline to Week 54]
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NT-ProBNP/BNP
[Time Frame: Baseline to Week 54]
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Secondary ID(s)
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AC-055-506
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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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