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Oxygen DeficiencyPhase 2SOPHANCT04207593

The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With Hypoxemia

A Phase 2 study testing Oxygen in people with Oxygen Deficiency and Pulmonary Arterial Hypertension, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxygen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteGermany
Study dates
1 Apr 2019to 10 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Centre for pulmonary hypertension of the Thoraxclinic at the University Hospital Heidelberg

    Heidelberg, 69126

Other trials in Germany

About this study

Official 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

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.

Read the detailed description

Most patients with PAH, except those with congenital heart defects and pulmonary-to-systemic shunts, have minor degrees of hypoxemia at rest and during the night.Current recommendations including the pneumological guidelines for LTOT are based on evidence in patients with chronic obstructive pulmonary disease, as data for patients with PH are lacking: When O2 partial pressure is repeatedly <8 kPa (<60 mmHg, alternatively, 90% of O2 saturation), patients are advised to use O2 to achieve a saturation of >8 kPa. The use of ambulatory O2 can be considered when there is evidence of a symptomatic response or correction of exercise-induced desaturation.

There are only few studies investigating the effect of oxygen supply in pulmonary hypertension, most of which merely investigate acute effects of O2 administration. Short-term oxygen administration has been shown to reduce mean pulmonary arterial pressure, pulmonary vascular resistance and to increase cardiac output in PAH patients. In one study, oxygen supply also reversed the progression of PH in patients with chronic obstructive pulmonary disease (COPD). One recent randomized-controlled trial indicates that O2 given during cardiopulmonary exercise significantly improves maximal work rate and endurance. Furthermore, nocturnal oxygen supply for one week significantly improved 6-minute walking distance in patients with PH, sleep-associated breathing difficulties, exercise performance during the day as well as cardiac repolarisation. Patients with Eisenmenger's syndrome gain little benefit from nocturnal O2 therapy.

Whether these positive effects of O2 supplementation during exercise would translate into long-term improvements of exercise capacity, quality of life, hemodynamics and disease progression is not known to date. Up to now, there are no randomised studies suggesting that long-term O2 therapy is indicated or when it should be initiated.

Being tested
Oxygen
Keywords
Oxygen, Pulmonary Arterial Hypertension, CTEPH, 6MWD
Medical subject headings
Hypoxia, Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxygenDrug

    Also called Liquid oxygen

    Study medication will be oxygen (O2) in diverse concentrations, titrated until a SaO2>90% or pO2 >60 mmHg is achieved, for 20 patients vs. no supplemental O2 for 20 patients over 90 ± 7 days. Patients of the control group will be offered to participate in the interventional treatment arm after they have terminated the control period (partial cross-over; secondary intervention group). After the end of the study it is up to the judgment of the investigator to prescribe oxygen to all patients who might benefit from the treatment.

Study groups in NCT04207593
Study groupRoleWhat they receive
Oxygen Therapy providedActive comparatorPatients will be divided in a supplemental-oxygen group (primary intervention group) throughout the study
Receives: Drug: Oxygen
no-supplemental-oxygen group (control group)Sham comparatorPatients of the control group will beginn the study without Oxygen Therapie and will be offered to participate in the interventional treatment arm after they have terminated the control period (partial cross-over; secondary intervention group).
Receives: Drug: Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from baseline to 6 months

Secondary outcomes (23)

  1. 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

    Measured: Change from baseline to 6 months

  2. 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

    Measured: Change from baseline to 6 months

  3. Clinical worsening; frequency and type of clinical worsening events

    To assess time to worsening of oxygen saturation and time to clinical worsening

    Measured: clinical worsening events from baseline to 6 months

  4. cardiac index in liters per minute per square meter (of body surface area) /(CI)

    Assessment of Cardiac Index during RHC

    Measured: Change from baseline to 6 months

  5. systolic pulmonary arterial pressure

    Right heart catheterization

    Measured: Change from baseline to 6 months

  6. mean pulmonary arterial pressure

    Right heart catheterization

    Measured: Change from baseline to 6 months

  7. pulmonary arterial wedge pressure

    Right heart catheterization

    Measured: Change from baseline to 6 months

  8. right atrial pressure

    Right heart catheterization

    Measured: Change from baseline to 6 months

  9. pulmonary vascular resistance (PVR)

    Right heart catheterization

    Measured: Change from baseline to 6 months

  10. cardiac output and ejection fraction (CO, HZV)

    Right heart catheterization

    Measured: Change from baseline to 6 months

  11. cardiac index (CI)

    Right heart catheterization

    Measured: Change from baseline to 6 months

  12. blood gas analysis from pulmonary artery

    central venous saturation

    Measured: Change from baseline to 6 months

  13. Change in systolic pulmonary arterial pressure

    Echocardiography and Stress Doppler Echocardiography

    Measured: Change from baseline to 6 months

  14. Echocardiography and Stress Doppler Echocardiography

    right ventricular pump function

    Measured: Change from baseline to 6 months

  15. Peak oxygen consumption

    Cardiopulmonary exercise testing

    Measured: Change from baseline to 6 months

  16. Peak oxygen consumption/kg body weight

    Cardiopulmonary exercise testing

    Measured: Change from baseline to 6 months

  17. oxygen Saturation

    Cardiopulmonary exercise testing

    Measured: Change from baseline to 6 months

  18. oxygen equivalent

    Cardiopulmonary exercise testing

    Measured: Change from baseline to 6 months

  19. Cardiopulmonary exercise testing

    carbon dioxide equivalent

    Measured: Change from baseline to 6 months

  20. Oxygen pulse

    Cardiopulmonary exercise testing

    Measured: Change from baseline to 6 months

  21. ventilatory threshold

    Cardiopulmonary exercise testing

    Measured: Change from baseline to 6 months

  22. respiratory reserve

    Cardiopulmonary exercise testing

    Measured: Change from baseline to 6 months

  23. World Health Organization functional classification

    Functional assessment of pulmonary hypertension

    Measured: Change from baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2019
  2. Study start1 Apr 2019
  3. Primary completion1 Jan 2023
  4. Study completion10 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04207593
Sponsor's protocol ID
2018-11SO*
Acronym
SOPHA
Status last verified
Jun 2024
First submitted
17 Dec 2019
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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. 2017 Apr 14;38(15):1159-1168. doi: 10.1093/eurheartj/ehx099.

    PubMed 28329240

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxygen in people with Oxygen Deficiency and Pulmonary Arterial Hypertension, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute Walking distance (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04207593, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.

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