Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
NCT ID: NCT02583906
Last Updated: 2023-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2014-04-30
2019-05-31
Brief Summary
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Detailed Description
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The secondary endpoints are the effect of CPAP on right atrium and right ventricle diameter and ejection fraction measured by echocardiography, 6 minutes walk distance, NYHA class, QOL, endothelial function, sympathetic activity and prognosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cpap treatment
patients randomized to the 'no cpap' arm will not be treated by CPAP
CPAP
Treatment with CPAP for six months in the CPAP arm.
no cpap
patients randomized to the 'cpap' arm will be treated by CPAP
No interventions assigned to this group
Interventions
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CPAP
Treatment with CPAP for six months in the CPAP arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension
* diagnosis of PAH based on cardiac catherisation
* diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy
* recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before inclusion showing AHI above 15) stable clinical condition for at least 3 months before inclusion as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months
Exclusion Criteria
* moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1\<60% of the predicted value
* BMI 35kg/m2 or more
* patients already treated with CPAP
* patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Catharina Belge, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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UZ Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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S55742
Identifier Type: -
Identifier Source: org_study_id
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