Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment

Conditions
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Sleep-Disordered Breathing, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension

Intervention / Treatment
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* Device: CPAP


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cpap treatment<br>patients randomized to the 'no cpap' arm will not be treated by CPAP | Device: CPAP<br>* Treatment with CPAP for six months in the CPAP arm.<br>* Other names: CONTINUOUS POSITIVE AIRWAY PRESSURE;|
| No Intervention: no cpap<br>patients randomized to the 'cpap' arm will be treated by CPAP | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PVR (pulmonary vascular resistance) |  | change in PVR from inclusion at 6 months |