pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)
Conditions
Interventions
Trade Name: Oxygen, liquid
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: OXYGEN
Other descriptive name: Sauerstoff
Sponsors
Thoraxklinik-Heidelberg gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients in both groups (n = 40) with precapillary PH, WHO class I -IV (mPAP = 25 mm Hg, pulmonary arterial occlusion pressure =15 mm Hg), who are stable on optimized pharmacological treatment for at least six weeks and who do not suffer from other cardio-pulmonary disease will be recruited if arterial or capillary O2 partial pressure is repeatedly (=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Patient is a female who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control - patient has already been treated with long-term oxygen therapy within the last 3 weeks. - patient with pulmonary venous hypertension - significant functional limitation in lung function tests (FEV1>60%,TLC <60%) and CT morphological signs of pulmonary disease - significant left heart disease, requires acute pharmacological or interventional treatment - unstable conditions requiring pharmacological or other treatment, intensive care or relevant severe concomitant disease - patient is enrolled, has participated within the last thirty days, or is planning to participate, in a concurrent drug and/or device study during the course of this clinical trial. Co-enrolment in concurrent trials is only allowed with documented pre-approval from the study manager that there is not a concern that co-enrolment could confound the results of this trial. - patient has been initiated on a new oral or parenteral PAH therapy in the last two months - patient has had a recent (within three months) or otherwise unresolved infection requiring antibiotic treatment - patient with a cardiac index (CI) <1.8L/min/m2 - patient is Functional Class IV (New York Heart Association (NYHA)) active smoking status - patient with severe resting desaturation (repeatedly SpO2 =85%) or severe exercise-induced desaturation (SpO2 <80% for =10 minutes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the benefits for PH patients from a long-term oxygen therapy (LTOT) given continuously during =16h/day for 12 weeks, measured by improvement of exercise performance assessed by the 6 minute walking distance (6MWD);Secondary Objective: 1) To investigate effects of oxygen treatment on QoL, measured with SF-36 questionnaire 2) To determine the hemodynamic and functional responses during long term oxygen treatment by echocardiography and right heart catheterisation 3) To investigate the change of clinical parameters such as blood gas analysis, laboratory (NT-proBNP), WHO functional class (WHO-FC) 4) To assess time to worsening of oxygen saturation ;Primary end point(s): To determine the benefits for PH patients from a long-term oxygen therapy (LTOT) given continuously during =16h/day for 12 weeks, measured by improvement of exercise performance assessed by the 6 minute walking distance (6MWD);Timepoint(s) of evaluation of this end point: 12 weeks after treatment start with or without oxygen | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To investigate effects of oxygen treatment on QoL, measured with SF-36 questionnaire - To determine the hemodynamic and functional responses during long term oxygen treatment by echocardiography and right heart catheterisation - To investigate the change of clinical parameters such as blood gas analysis, laboratory (NT-proBNP), WHO functional class (WHO-FC) - To assess time to worsening of oxygen saturation and time to clinical worsening;Timepoint(s) of evaluation of this end point: 12 weeks after treatment start with or without oxygen | — |
Countries
Germany
Contacts
Public ContactCentre for pulmonary hypertension
Thoraxklinik Heidelberg gGmbH
Outcome results
None listed