Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension - a Prospective, Descriptive Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- AHI change under CTEPH treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently diagnosed untreated CTEPH
- •NYHA I-III
排除标准
- •Pulmonary Hypertension other than CTEPH
- •Previous diagnosis of SDB
- •Ongoing PAP treatment
- •Use of nasal oxygen
研究组 & 干预措施
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.
干预措施: Pulmonary Endarteriectomy (Procedure)
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.
干预措施: Ballon Pulmonary Angioplasty (Procedure)
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.
干预措施: Riociguat (Drug)
结局指标
主要结局
AHI change under CTEPH treatment
时间窗: 6 months
Change from baseline AHI (Apnoe-Hypopnoe Index, events/h) after 6 months of CTEPH treatment
次要结局
- Number of patients with persisting elevated AHI (= ≥15/h) after CTEPH treatment(Time point: 6 months after the individual start of the CTEPH treatment)
研究者
Klaus Hackner, MD
Principal Investigator
Medical University of Vienna