Trial · NCT04915300
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Placebo-corrected change from baseline in PVR at week 24 | Baseline, and 24 weeks later | Right heart catheterization: Measuring PVR is performed in a standardized manner in catheterization laboratories of the participating centres, according to recommendations. Printed copies of waveforms will be kept for monitoring visits and documentation of the accuracy of the pressures and calculations. |
| Secondary | Changes at week 24 in 6MWD | Baseline, week 8 and week 24 | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. |
| Secondary | Changes at week 24 in plasma NT-proBNP concentration | Baseline, week 8 and week 24 | |
| Secondary | Changes at week 24 in WHO functional class | Baseline, week 8 and week 24 | There are four functional classes that are used to rate how ill PH patients are. Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: Symptoms at rest and severe symptoms with any activity. |
| Secondary | Changes at week 24 in European Respiratory Society (ERS)/European Society of Cardiology (ESC) risk stratification score | Screening and Week 24 | The ERS/ESC risk stratification strategy will be used to categorize patients as low, intermediate or high risk. The cut-off values proposed in the guidelines will be graded 1-3 (1: low-, 2: intermediate- and 3: high-risk). For each patient, the sum of all grades will be divided by the number of variables and rounded to the next integer to define the risk group. The number of low-risk criteria per patients will also be assessed. |
| Secondary | Change at week 24 in mean Pulmonary Artery Pressure (mPAP), mmHg obtained from right heart catheterization | Screening and Week 24 | The hemodynamic definition of pulmonary arterial hypertension (PAH) is a mean pulmonary artery pressure at rest greater than or equal to 25 mmHg in the presence of a pulmonary capillary wedge pressure less than or equal to 15 mmHg. These measurements can only be taken accurately during a right heart catheterization. |
| Secondary | Change in cardiac output (L/min) | Screening and Week 24 | Catheterization |
| Secondary | Change in right atrial pressure (RAP), mmHg | Screening and Week 24 | Catheterization |
| Secondary | Change in mixed venous oxygen saturation (SvO2), % | Screening and Week 24 | Catheterization |
| Secondary | Change at week 24 in HRQoL assessed using the EmPHasis-10 questionnaire | Screening and Week 24 | The Emphasis-10 questionnaire is a short questionnaire for assessing HRQoL in pulmonary arterial hypertension. It has excellent measurement properties and is sensitive to differences in relevant clinical parameters. |
| Other | Change in clinical worsening events | Baseline and Week 24 | Win ratio methodology will be used to evaluate the effects of apabetalone compared to placebo on mortality and clinically relevant morbidity events. The pairwise comparison proceeds in hierarchical fashion, using 1) all-cause mortality, followed by 2) frequency of PAH-related hospitalization; 3) a placebo-corrected change from baseline 6-minute walk distance \>35 meters and; 4) a \>20% relative placebo-corrected change in NTproBNP levels from baseline using the win ratio methodology. This method is based on the principle that each patient is compared with every other patient in a pairwise manner. This method gives a higher importance to all-cause mortality, followed by frequency of PAH-related hospitalization, exercise capacity and natriuretic peptide when patients cannot be differentiated on the basis of mortality, hospitalizations and functional status, respectively. |
| Other | Circulating levels change in whole blood markers of metabolism | Baseline and Week 24 | Adiponectin, ApoA-I, LDL-C and HDL-C |
| Other | Circulating levels change in whole blood markers of vascular calcification | Baseline and Week 24 | Alkaline phosphatase, osteoprotegerin, osteopontin, RUNX2 |
| Other | Circulating levels change in whole blood markers of inflammation | Baseline and Week 24 | C-reactive protein, fibrinogen, and inflammatory cytokines including IL-1 and IL-6 |
| Other | Circulating levels change in whole blood markers of DNA damage | Baseline and Week 24 | Comet assay, PARP1 expression |
| Other | Change in PBMC expression of BMPR2 | Baseline and Week 24 | The proportion of patients with mutations in BMPR2 and key genes of the HR repair pathway |
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.
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