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

Not Applicable

Terminated

• Conditions: Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Sleep-Disordered Breathing
• Interventions: Device: CPAP

• Registration Number: NCT02583906
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2020-11
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cpap treatment	CPAP	patients randomized to the 'no cpap' arm will not be treated by CPAP

Primary Outcome Measures

Name	Time	Method
Change in PVR (pulmonary vascular resistance)	change in PVR from inclusion at 6 months

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium