Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

Not Applicable

Completed

• Conditions: Sleep Disordered Breathing; Chronic Thromboembolic Pulmonary Hypertension
• Interventions: Procedure: Pulmonary Endarteriectomy; Procedure: Ballon Pulmonary Angioplasty; Drug: Riociguat

• Registration Number: NCT03074539
• Lead Sponsor: Medical University of Vienna

Brief Summary

There is evidence for a high prevalence of Sleep Disorder Breathing (SDB) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Central Sleep Apnea, Cheyne-Stokes Breathing and Obstructive Sleep Apnea appear to occur in CTEPH. However, there is no information on the impact of CTEPH treatment modalities on concomitant SDB. Furthermore, the use of PAP therapy in CTEPH has not yet been investigated. CTEPH is a rare and serious disease and there may be a bidirectional association of SDB and CTEPH.

This study plans to investigate the prevalence of SDB in CTEPH and compare it to datasets of large epidemiological studies on SDB. Furthermore, the impact of CTEPH treatment on SDB will be analyzed and CTEPH patients for possible PAP treatment will be defined.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-08
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Recently diagnosed untreated CTEPH
• NYHA I-III

Exclusion Criteria

• Age<18
• Pulmonary Hypertension other than CTEPH
• Previous diagnosis of SDB
• Ongoing PAP treatment
• Use of nasal oxygen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary Endarteriectomy - PEA	Pulmonary Endarteriectomy	CTEPH treatment via PEA. This arm includes patients who will receive Pulmonary Endarteriectomy (PEA) according to local CTEPH board recommendation. A standardized polygraphy will be conducted before the PEA - intervention, to obtain information concerning Sleep Disorder Breathing. 6 months after the PEA surgery another polygraphy will be accomplished and the results compared with the first polygraphy and the other arms. If Sleep Disorder Breathing remains, a personalized recommendation on further specific therapy (e.g. nocturnal continuous positive airway pressure ventilation) will be made.
Balloon Pulmonary Angioplasty - BPA	Ballon Pulmonary Angioplasty	CTEPH treatment via BPA. Patients who are suitable for Balloon Pulmonary Angioplasty (BPA) according to the recommendation of the local CTEPH board (e.g. patients not suitable for Pulmonary Endarteriectomy). A standardized polygraphy will be conducted before the first BPA intervention, to gain information about possible sleep-disordered breathing. 6 months after the first BPA intervention another polygraphy will be accomplished and the results compared with the first polygraphy and the other arms. If Sleep Disorder Breathing remains, a personalized recommendation on further specific therapy (e.g. nocturnal continuous positive airway pressure ventilation) will be made.
Medical Treatment	Riociguat	CTEPH treatment via Medical Treatment. Patients who are inoperable (not suitable for Pulmonary Endarteriectomy) and not eligible for BPA according to the recommendation of the local CTEPH board will get medical treatment with Riociguat. The treatment will be assigned according to the currently valid guidelines (2015 European Respiratory Society / European Society of Cardiology guidelines on the diagnosis and treatment of pulmonary hypertension). A standardized polygraphy will be conducted before the medical treatment starts, another polygraphy will be conducted after 6 months of treatment if Riociguat. The results will be compared with the first polygraphy and the other arms. If Sleep Disorder Breathing remains, a personalized recommendation on further specific therapy (e.g. nocturnal continuous positive airway pressure ventilation) will be made.

Primary Outcome Measures

Name	Time	Method
AHI change under CTEPH treatment	6 months	Change from baseline AHI (Apnoe-Hypopnoe Index, events/h) after 6 months of CTEPH treatment

Secondary Outcome Measures

Name	Time	Method
Number of patients with persisting elevated AHI (= ≥15/h) after CTEPH treatment	Time point: 6 months after the individual start of the CTEPH treatment	Patients with persisting elevated AHI will be assessed for further PAP treatment

Trial Locations

Locations (1)

Medical Unviersity Vienna; 🇦🇹 Vienna, Austria