Back to resultsSleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
Primary Purpose
Sleep-Disordered Breathing, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Sleep-Disordered Breathing
Eligibility Criteria
Inclusion Criteria:
- minimum 18 years old
- 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:
- congenital heart disease
- 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)
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
cpap treatment
no cpap
Arm Description
patients randomized to the 'no cpap' arm will not be treated by CPAP
patients randomized to the 'cpap' arm will be treated by CPAP
Outcomes
Primary Outcome Measures
Change in PVR (pulmonary vascular resistance)
Secondary Outcome Measures
Full Information
NCT ID
NCT02583906
First Posted
April 28, 2014
Last Updated
January 26, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT02583906
Brief Title
Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
Official Title
Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Not enough participants
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing.
Detailed Description
The primary endpoint of the study is to evaluate the effect of CPAP therapy on pulmonary vascular resistance in PAH and CTEPH patients suffering from sleep disordered breathing.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-Disordered Breathing, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cpap treatment
Arm Type
Other
Arm Description
patients randomized to the 'no cpap' arm will not be treated by CPAP
Arm Title
no cpap
Arm Type
No Intervention
Arm Description
patients randomized to the 'cpap' arm will be treated by CPAP
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
CONTINUOUS POSITIVE AIRWAY PRESSURE
Intervention Description
Treatment with CPAP for six months in the CPAP arm.
Primary Outcome Measure Information:
Title
Change in PVR (pulmonary vascular resistance)
Time Frame
change in PVR from inclusion at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
minimum 18 years old
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:
congenital heart disease
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catharina Belge, MDPhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
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