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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02583906

Enrollment

Registered

2015-10-22

Start date

2014-04-30

Completion date

2019-05-31

Last updated

2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICECPAP

Treatment with CPAP for six months in the CPAP arm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Change in PVR (pulmonary vascular resistance)	change in PVR from inclusion at 6 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026