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Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

Primary Purpose

Chronic Thromboembolic Pulmonary Hypertension, Sleep Disordered Breathing

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Riociguat
Pulmonary Endarteriectomy
Ballon Pulmonary Angioplasty
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Thromboembolic Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Unviersity Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pulmonary Endarteriectomy - PEA

Balloon Pulmonary Angioplasty - BPA

Medical Treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients with persisting elevated AHI (= ≥15/h) after CTEPH treatment
Patients with persisting elevated AHI will be assessed for further PAP treatment

Full Information

First Posted
February 14, 2017
Last Updated
March 13, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03074539
Brief Title
Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension
Official Title
Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension - a Prospective, Descriptive Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Pulmonary Hypertension, Sleep Disordered Breathing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary Endarteriectomy - PEA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Balloon Pulmonary Angioplasty - BPA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Medical Treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Riociguat
Other Intervention Name(s)
Adempas
Intervention Description
Patients will be treated with Riociguat according to guidelines (2015 ERS/ESC guidelines for the diagnosis and treatment of pulmonary hypertension) and manufacturers recommendation.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Endarteriectomy
Other Intervention Name(s)
PEA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ballon Pulmonary Angioplasty
Other Intervention Name(s)
BPA
Intervention Description
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.
Primary Outcome Measure Information:
Title
AHI change under CTEPH treatment
Description
Change from baseline AHI (Apnoe-Hypopnoe Index, events/h) after 6 months of CTEPH treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of patients with persisting elevated AHI (= ≥15/h) after CTEPH treatment
Description
Patients with persisting elevated AHI will be assessed for further PAP treatment
Time Frame
Time point: 6 months after the individual start of the CTEPH treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Lang, Prof.
Organizational Affiliation
Medical University Vienna
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Unviersity Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

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