Trial · NCT06350032
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency and seriousness of adverse events and adverse drug reactions | 5 months (20 weeks ± 1 weeks) | The frequency and seriousness of adverse events and adverse drug reactions during the first 5 months (20 weeks ± 1 weeks) of treatment according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). |
| Other | Change from baseline in quality of Life (QoL) | 5 months (20 weeks ± 1 weeks) | Change from baseline in quality of Life (QoL) as assessed by the Pediatric Quality of Life Inventory (PedsQoL Version 4.0) questionnaire. Rating from 0 (never) to 4 (almost always) per question. Questionnaire will be completed by pediatric patient (version appropriate for age group) and parents/caregivers. |
| Other | Change from baseline in 6-minute walk distance (6MWD) | 5 months (20 weeks ± 1 weeks) | Change from baseline in 6MWD (patients \> 6 years) |
| Other | Change from baseline in World Health Organization Functional Class (WHO FC) | 5 months (20 weeks ± 1 weeks) | Change in WHO FC class assessment based on current PH guidelines ranging from class I to class IV, whereas class IV means severe limitations. |
| Other | Change from baseline in echocardiography (ECHO) parameters - RA/RV enlargement | 5 months (20 weeks ± 1 weeks) | right atrium (RA) / right ventricle (RV) |
| Other | Change from baseline in echocardiography (ECHO) parameters - RV systolic dysfunction | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in echocardiography (ECHO) parameters - RV/LV end-systolic ratio (PSAX) | 5 months (20 weeks ± 1 weeks) | RV / left ventricle (LV) |
| Other | Change from baseline in echocardiography (ECHO) parameters - tricuspid annular plane systolic excursion (TAPSE) | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in echocardiography (ECHO) parameters - S/D ratio (TR jet) | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in echocardiography (ECHO) parameters - Pulmonary Artery Acceleration Time (PAAT) | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in echocardiography (ECHO) parameters - pericardial effusion | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in echocardiography (ECHO) parameters - eccentricity index | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in echocardiography (ECHO) parameters - acceleration time | 5 months (20 weeks ± 1 weeks) | |
| Other | Change from baseline in plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) levels | 5 months (20 weeks ± 1 weeks) | |
| Other | Treprostinil plasma concentration | 5 months (20 weeks ± 1 weeks) | For treprostinil plasma concentration analysis one 0,5 ml blood sample for patients ≤ 20 kg and one 1ml blood (K3-EDTA) sample for patients \> 20kg will be taken. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06350032/registered