Skip to main content
OpenTrials
Completed

NCT Number: NCT03074539

Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disordered Breathing Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Unviersity Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Adempas

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.

Other names: 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.

Other names: BPA

Primary outcomes

  1. AHI change under CTEPH treatment

    Time frame: 6 months

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

Secondary outcomes

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

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

    Patients with persisting elevated AHI will be assessed for further PAP treatment

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2017
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.