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

Universitaire Ziekenhuizen KU Leuven

Status

Terminated

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Sleep-Disordered Breathing

Pulmonary Arterial Hypertension

Treatments

Device: CPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT02583906

S55742

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)