Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension - a Prospective, Descriptive Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disordered Breathing; Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Procedure: Pulmonary Endarteriectomy; Procedure: Ballon Pulmonary Angioplasty; Drug: Riociguat

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaus Hackner, M.D.; Phone Number: +43273290044368; Email: klaus.hackner@gmx.at
• Study Contact Backup: Name: Matthias Maurer; Phone Number: +43273290044368

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical Unviersity Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulmonary Endarteriectomy - PEA; 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.	Procedure: Pulmonary Endarteriectomy; Patients will receive Pulmonary Endarteriectomy if they are suitable for this procedure according to the recommendation of the local CTEPH board. Patients must also consent to this surgical procedure.; Other Names: PEA
Active Comparator: Balloon Pulmonary Angioplasty - BPA; 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.	Procedure: Ballon Pulmonary Angioplasty; Patients will receive Ballon Pulmonary Angioplasty if they are suitable for this procedure according to the recommendation of the local CTEPH board (e.g. not suitable for PEA). Patients must also consent to this procedure.The BPA will be accomplished in several interventions.; Other Names: BPA
Active Comparator: Medical Treatment; 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.	Drug: Riociguat; Patients will be treated with Riociguat according to guidelines (2015 ERS/ESC guidelines for the diagnosis and treatment of pulmonary hypertension) and manufacturers recommendation.; Other Names: Adempas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AHI change under CTEPH treatment	Change from baseline AHI (Apnoe-Hypopnoe Index, events/h) after 6 months of CTEPH treatment	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Study Chair: Irene Lang, Prof., Medical University Vienna

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Sleep Apnea Syndromes; Hypertension; Respiratory Aspiration; Hypertension, Pulmonary; Molecular Mechanisms of Pharmacological Action; Enzyme Activators; Riociguat
• Other Study ID Numbers: CTEPH_SDB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No