Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

Medical University of Vienna50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Chronic Thromboembolic Pulmonary Hypertension Sleep Disordered Breathing

Interventions

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

Pulmonary EndarteriectomyPROCEDURE

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.

Ballon Pulmonary AngioplastyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Unviersity Vienna

Vienna, Austria

Outcomes

Primary Outcomes

AHI change under CTEPH treatment

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

Time frame: 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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