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NCT04207593: SOPHA
The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With Hypoxemia
Phase 2 trial testing Oxygen in Oxygen Deficiency in 20 participants. Completed in 10 January 2023.
1 January 2023
Quick facts
| Lead sponsor | Heidelberg University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 April 2019 |
| Primary completion | 1 January 2023 |
| Estimated completion | 10 January 2023 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Oxygen — full drug profile →
Conditions studied
- Oxygen Deficiency — all drugs for Oxygen Deficiency →
- Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →
- CTEPH — all drugs for CTEPH →
Sponsor
Heidelberg University
Who can join
18 and older, any sex, with Oxygen Deficiency or Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Long-term oxygen therapy in precapillary pulmonary hypertension - SOPHA study.
Benjamin N, Echampati I, Harutyunova S, Eichstaedt CA, et al · · 2024 · PMID 39327434 · DOI 10.1038/s41598-024-70650-w
Verify or expand the search:
- PubMed search for NCT04207593
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oxygen
Trials testing the same drug.
- NCT06327373 — A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia · Phase 1, PHASE2 · not yet recruiting
- NCT07464730 — Postoperative High-flow Nasal Oxygenation After High-risk Surgery in the Frail Adult · NA · not yet recruiting
- NCT06498908 — Intracervical Balloon Placement With Nitrous Oxide Administration · Phase 3 · withdrawn
- NCT07245628 — A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy · EARLY_PHASE1 · recruiting
- NCT07369232 — Cerebral Hemodynamic Effects of Oxygen and Antioxidants (CHEOXANT) · NA · recruiting
Other recruiting trials for Oxygen Deficiency
Currently open trials in the same condition.
- NCT06475261 — Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy · recruiting
- NCT06404151 — Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients · recruiting
Other Heidelberg University trials
Trials by the same sponsor.
- NCT07106294 — Hyperspectral Imaging for Prediction of Preeclampsia · recruiting
- NCT06651164 — Psychosomatic Risk Screening · NA · completed
- NCT07378345 — Optimization of Communication Between Surgery and Pathology · NA · completed
- NCT06018272 — Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany · NA · recruiting
- NCT06852599 — Long-term Outcomes of Implants in Patients with Periodontitis · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04207593 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Heidelberg University
- Last refreshed: 20 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04207593.
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