A prospective, randomized, controlled trial to assess the effect of long-term oxygen therapy on 6-minute walking distance, clinical parameters and hemodynamics in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) - SOPHA

Thoraxklinik-Heidelberg gGmbH0 sites40 target enrollmentJanuary 30, 2019

DrugsOxygen, liquid

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Thoraxklinik-Heidelberg gGmbH
Enrollment: 40
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 30, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Thoraxklinik-Heidelberg gGmbH

Eligibility 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 (\<60 mmHg; alternatively, 90% of O2 saturation) at rest and during physical activity hypoxemia still persist (O2 partial pressure \<60 mmHg SpO2 90 % ). \- men and women 18 years of age or older \- patient is diagnosed with Pulmonary Arterial Hypertension (World Health Organization (WHO) Category Group 1\-3 (by the WHO Clinical classification system)), including Idiopathic (IPAH), Heritable PAH (HPAH, Familial PAH), and CTEPH, with exceptions as noted in exclusion criteria \- patient (or patient's legally authorized representative) is willing and able to provide written informed consent \- patient is willing and able to comply with the protocol, including required follow\-up visits \- Patient experiences oxygen desaturations below 90% (or pO2 below 60 mmHg) at rest with oxygen desaturations below 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 six weeks before inclusion
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 20
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 20

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)