Trial · NCT06603285
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in NT-proBNP | Week 97 | Calculate the \"N terminal pro B type natriuretic peptide\" change from baseline to Week 97 |
| Primary | Change from baseline in WHO functional class | Week 97 | Calculate the World Health Organization functional class change from baseline to Week 97. The World Health Organization (WHO) functional class describes how severe a patient\'s pulmonary hypertension (PH) symptoms are. There are four different classes - I is the mildest and IV is the most severe form of PH. |
| Secondary | Time to clinical worsening and death | 96 weeks | Record the time to clinical worsening and death |
| Secondary | Change from baseline in NT-proBNP | Week 13, 25, 37, 49, 61, 73, and 85 | Calculate the change from baseline in NT-proBNP at Week 13, 25, 37, 49, 61, 73, and 85 |
| Secondary | Change from baseline in 6-minute walk distance (6MWD) | Week 25, 49, 73, and 97 | Calculate the cange from baseline in 6-minute walk distance (6MWD) at Week 25, 49, 73, and 97 |
| Secondary | Trend of dose usage from initiation treatment to clinical worsening | 96 weeks | Record all the daily doses which the patients administered during the whole study period |
| Secondary | Adverse events of special interest (AESIs) | 96 weeks | AESIs include infusion site pain, infusion site reaction, headache, diarrhea, nausea, rash, jaw pain, hot flashes, vasodilation, and edema |
| Secondary | Change from baseline in WHO functional class | Week 13, 25, 37, 49, 61, 73, and 85 | Calculate the change from baseline in WHO functional class at Week 13, 25, 37, 49, 61, 73, and 85 The World Health Organization (WHO) functional class describes how severe a patient\'s pulmonary hypertension (PH) symptoms are. There are four different classes - I is the mildest and IV is the most severe form of PH. |
| Secondary | Change from baseline in right atrium (RA) area | Week 25, 49, 73, and 97 | RV structure and function will be monitored by echocardiography, including Right atrium (RA) area. |
| Secondary | Change from baseline in TAPSE/sPAP ratio. | Week 25, 49, 73, and 97 | RV structure and function will be monitored by echocardiography, including Tricuspid annular plane systolic excursion (TAPSE) / systolic pulmonary artery pressure (sPAP) ratio. |
| Secondary | Change from baseline in Pericardial effusion. | Week 25, 49, 73, and 97 | RV structure and function will be monitored by echocardiography, including Pericardial effusion. |
| Secondary | Change from baseline in modified Borg Dyspnea Scale | Week 25, 49, 73, and 97 | Calculate the change from baseline in modified Borg Dyspnea Scale at Week 25, 49, 73, and 97. The modified Borg Dyspnea scales are patient self-reported measures of one's difficulty in breathing upon exertion. The Scale is a categorical scale with a score from 0 to 10, where 0 represents normal breathing and 10 represents maximum dyspnea. |
| Secondary | Change from baseline in SF-36 questionnaire | Week 25, 49, 73, and 97 | Calculate the change from baseline in SF-36 questionnaire at Week 25, 49, 73, and 97. The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. It comprises 36 questions that cover eight domains of health. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL. |
| Secondary | Intercurrent event | 96 weeks | Intercurrent events includes consent withdrawn, use of rescue medication, discontinuation from treprostinil treatment, PAH unrelated hospitalization, switch to other PAH drugs (other than treprostinil), add-on PAH drugs, or new-onset co-morbidity. |
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/NCT06603285/registered