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临床试验/DRKS00013897
DRKS00013897招募中不适用

Sleep-disordered breathing in patients with pulmonary arterial hypertension before and after effective treatment

Department für Neurologie - Klinik für Schlafmedizin und neuromuskuläre Erkrankungen (Direktor: Univ.-Prof. Dr. med. Peter Young)0 个研究点目标入组 20 人开始时间: 2018年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 70 Years(—)
性别
Male

入选标准

  • Invasively obtained diagnosis of PAH (mean pulmonary arterial pressure = 25 mmHg; post-capillary wedge pressure =15 mmHg; pulmonary vascular resistance > 3 Wood units)
  • -APAH due to (echocardiographically) proven congenital heart disease or due to (antinuclear antibody positive) connective tissue disease (systemic sclerosis) or IPAH with comprehensive investigations in order to exclude other causes of PAH
  • -No or ineffective treatment (untreated”), as defined by no clinical improvement (NYHA functional class > II) and/or persistent elevation or no near-to-normal reduction of NT-proBNP levels under current PAH medication
  • - Presence of SDB on cardiorespiratory polygraphy (AHI > 15/h)
  • -Age > 18 years and < 70 years
  • -Free ambulation
  • -Written informed consent to participate in the study
  • Additional inclusion criterion for post-treatment evaluation:
  • Positive treatment response as reflected by clinical improvement (NYHA I or II) and/or normal or near-to-normal of NT-proBNP.

排除标准

  • -Body Mass Index (BMI) > 35
  • -Heart failure with left ventricular ejection fraction <50%
  • -Chronic obstructive pulmonary disease, emphysema
  • -Presence of severe neurological comorbidities especially primary myopathy, muscular dystrophy, motor neuron disease, phrenic nerve disease, epilepsy, multiple sclerosis, parkinson’s disease
  • -Severe psychiatric disease including dementia
  • -Thoracic wall disease
  • -Cardiac pacemaker

研究者

发起方
Department für Neurologie - Klinik für Schlafmedizin und neuromuskuläre Erkrankungen (Direktor: Univ.-Prof. Dr. med. Peter Young)

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