Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

NCT03074539 | Completed

• 1 other identifier: CTEPH_SDB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension; Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• AHI change under CTEPH treatment

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

  6 months

Secondary Outcomes (1)

• Number of patients with persisting elevated AHI (= ≥15/h) after CTEPH treatment

  Time point: 6 months after the individual start of the CTEPH treatment

Study Arms (3)

Pulmonary Endarteriectomy - PEA

ACTIVE COMPARATOR

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

Balloon Pulmonary Angioplasty - BPA

ACTIVE COMPARATOR

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

Medical Treatment

ACTIVE COMPARATOR

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

Interventions

Riociguat DRUG

Patients will be treated with Riociguat according to guidelines (2015 ERS/ESC guidelines for the diagnosis and treatment of pulmonary hypertension) and manufacturers recommendation.

Also known as: Adempas

Medical Treatment

Pulmonary Endarteriectomy PROCEDURE

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.

Also known as: PEA

Pulmonary Endarteriectomy - PEA

Ballon Pulmonary Angioplasty PROCEDURE

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.

Also known as: BPA

Balloon Pulmonary Angioplasty - BPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recently diagnosed untreated CTEPH
• NYHA I-III

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical Unviersity Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

riociguat

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Irene Lang, Prof.

  Medical University Vienna

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 8, 2017
• Study Start: February 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

AU (1)