Pulmonary Arterial Hypertension Clinical Trial
— SOPHAOfficial title:
Prospective, Randomized, Controlled Trial of the Effect of Long-term Oxygen Therapy on 6-minute Walking Distance, Clinical Parameters and Hemodynamics in Patients With PAH and CTEPH
Verified date | June 2024 |
Source | Heidelberg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Treatment of O2 naïve patients with PAH will be included in this investigator-initiated trial (IIT) to assess efficacy and safety of oxygen substitution. Nocturnal oxygen substitution improved the 6MWD compared to placebo in one clinical trial in PAH patients. Due to the positive results in the treatment of patients with PAH, the initiation of this proof-of-concept study is justified.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 10, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria Patients in both groups (n = 20; n=10 each group) 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 (<60 mmHg; alternatively, 90% of O2 saturation) at rest and/or during physical activity (O2 partial pressure <60 mmHg pO2 90 % ). - men and women 18 years of age or older - patient is diagnosed with Pulmonary Arterial Hypertension (World Health Organization (WHO) Category Group 1 (by the WHO Clinical classification system)), including Idiopathic (IPAH), Heritable PAH (HPAH, Familial PAH), associated PAH (APAH) and CTEPH, with exceptions as noted in exclusion criteria - patient is willing and able to provide written informed consent - patient is willing and able to comply with the protocol, including required follow-up visits - Patients experiencing oxygen desaturations =90% (or pO2 below 60 mmHg) at rest and/or oxygen desaturations =90% (or pO2 below 60 mmHg) during physical activity - patient has a stable functional class of PAH with no changes of medication during the last two weeks before inclusion 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 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, requiring 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 weekspatient with a cardiac index (CI) <1.8L/min/m^2 - active smoking Status - patient with severe resting desaturation (repeatedly SpO2 <80%) or severe exercise-induced desaturation (SpO2 =75% for =10 minutes) |
Country | Name | City | State |
---|---|---|---|
Germany | Centre for pulmonary hypertension of the Thoraxclinic at the University Hospital Heidelberg | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University |
Germany,
Ulrich S, Hasler ED, Saxer S, Furian M, Muller-Mottet S, Keusch S, Bloch KE. Effect of breathing oxygen-enriched air on exercise performance in patients with precapillary pulmonary hypertension: randomized, sham-controlled cross-over trial. Eur Heart J. 2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-minute Walking distance | 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). | Change from baseline to 6 months | |
Secondary | Quality of life: physical Summation score; short form health Survey 36 (score from 0-100; higher scores indicating better outcome) | To investigate effects of oxygen treatment on QoL, physical Summation score measured with SF-36 questionnaire | Change from baseline to 6 months | |
Secondary | Quality of life: mental Summation score; short form health Survey 36 (score from 0-100; higher scores indicating better outcome) | To investigate effects of oxygen treatment on QoL, mental Summation score measured with SF-36 questionnaire | Change from baseline to 6 months | |
Secondary | Clinical worsening; frequency and type of clinical worsening events | To assess time to worsening of oxygen saturation and time to clinical worsening | clinical worsening events from baseline to 6 months | |
Secondary | cardiac index in liters per minute per square meter (of body surface area) /(CI) | Assessment of Cardiac Index during RHC | Change from baseline to 6 months | |
Secondary | systolic pulmonary arterial pressure | Right heart catheterization | Change from baseline to 6 months | |
Secondary | mean pulmonary arterial pressure | Right heart catheterization | Change from baseline to 6 months | |
Secondary | pulmonary arterial wedge pressure | Right heart catheterization | Change from baseline to 6 months | |
Secondary | right atrial pressure | Right heart catheterization | Change from baseline to 6 months | |
Secondary | pulmonary vascular resistance (PVR) | Right heart catheterization | Change from baseline to 6 months | |
Secondary | cardiac output and ejection fraction (CO, HZV) | Right heart catheterization | Change from baseline to 6 months | |
Secondary | cardiac index (CI) | Right heart catheterization | Change from baseline to 6 months | |
Secondary | blood gas analysis from pulmonary artery | central venous saturation | Change from baseline to 6 months | |
Secondary | Change in systolic pulmonary arterial pressure | Echocardiography and Stress Doppler Echocardiography | Change from baseline to 6 months | |
Secondary | Echocardiography and Stress Doppler Echocardiography | right ventricular pump function | Change from baseline to 6 months | |
Secondary | Peak oxygen consumption | Cardiopulmonary exercise testing | Change from baseline to 6 months | |
Secondary | Peak oxygen consumption/kg body weight | Cardiopulmonary exercise testing | Change from baseline to 6 months | |
Secondary | oxygen Saturation | Cardiopulmonary exercise testing | Change from baseline to 6 months | |
Secondary | oxygen equivalent | Cardiopulmonary exercise testing | Change from baseline to 6 months | |
Secondary | Cardiopulmonary exercise testing | carbon dioxide equivalent | Change from baseline to 6 months | |
Secondary | Oxygen pulse | Cardiopulmonary exercise testing | Change from baseline to 6 months | |
Secondary | ventilatory threshold | Cardiopulmonary exercise testing | Change from baseline to 6 months | |
Secondary | respiratory reserve | Cardiopulmonary exercise testing | Change from baseline to 6 months | |
Secondary | World Health Organization functional classification | Functional assessment of pulmonary hypertension | Change from baseline to 6 months |
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