Trial · NCT05493371
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tolerability: the number of patients who have to prematurely discontinue treatment due to intolerability or adverse events. | 12 weeks | |
| Primary | Feasibility: time needed to include all patients and number of patients needed to screen. | 12 weeks | |
| Primary | Safety: the number of adverse events (AEs), severe adverse events (SAEs), adverse event of special interest (AESI) and suspected unexpected serious adverse reactions (SUSARs). | 12 weeks | |
| Secondary | Right ventricle ejection fraction (RVEF) measured using MRI | 12 weeks | RVEF is calculated using the RVESV, RVEDV |
| Secondary | Right ventricle mass measured using MRI | 12 weeks | |
| Secondary | Left ventricle ejection fraction (LVEF) measured using MRI | 12 weeks | LVEF is calculated using the LVESV, LVEDV |
| Secondary | Stroke volume (SV) measured using MRI | 12 weeks | SV is calculated using the LVESV, LVEDV |
| Secondary | Tricuspid annular plane systolic excursion (TAPSE) measured using transthoracic ultrasound | 12 weeks | |
| Secondary | Estimated sPAP measured using transthoracic ultrasound | 12 weeks | |
| Secondary | Right ventricle fractional area change (RVFAC) measured using transthoracic ultrasound | 12 weeks | |
| Secondary | Blood biomarkers | 12 weeks | Endpoints: Expression of peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) and bone morphogenetic protein receptor II (BMPR2) in peripheral blood mononuclear cells (PMBC) |
| Secondary | Blood safety biomarkers | 12 weeks | Fasting glucose, N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP) and creatinine in blood. |
| Secondary | Urine safety biomarkers | 12 weeks | Ketones, nitrites, leukocytes and glucose in urine test strip (dipstick). |
| Secondary | Functional class | 12 weeks | World Health Organization Function Classification of Pulmonary Hypertension. Outcome: Class I, Class II, Class III or Class IV |
| Secondary | Six-Minute Walk Distance | 12 weeks | Six-minute walk distance (6MWD) will be measured by the 6-minute walk test (6MWT). The test should preferably be conducted on a straight 30 metre track. The patient is instructed to walk as far as possible for six minutes. One lap is demonstrated. The patient is told that slowing down can be necessary, and after pausing are encouraged to start walking as soon as possible. |
| Secondary | Quality of life measured with use of the EMPHASIS-10 questionnaire | 12 weeks | The emPHasis-10 is a short questionnaire for assessing Health-related quality of life in pulmonary arterial hypertension. The questionnaire comprises 10 items that are formatted as a semantic six-point differential scale and results in a score out of 50 where a higher score represents a higher symptom burden. |
| Secondary | Quality of life measured with use of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) questionnaire | 12 weeks | The CAMPHOR questionnaire contains 65 items in total. The measure consists of three different scales: a symptom scale assessing energy, breathlessness and mood (25-items; low score indicating minimal symptoms); activity limitations scale with a 3-point rating system (15-items; range 0 to 30, lower score indicating minimal activity limitation); and a QoL scale (25-items; lower score indicating better QoL). It is negatively weighted; a higher score indicates worse QoL and greater functional limitation. |
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/NCT05493371/registered