Trial · NCT04810091
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in NTproBNP at 6 Months Visit From Baseline | Baseline and at 6 months | Patients who had NTproBNP at both baseline and 6 months | Percent change from baseline | MEDIAN |
| SECONDARY | Change in 6MWT at 3 Month Visit | Baseline and 3 month follow-up | Of the 29 participants who completed 3-month follow-up in the Placebo + SSA arm, 25 completed the 6MWT at both baseline and 3 months. In the Xermelo + SSA arm, all 29 participants who completed 3-month follow-up also completed the 6MWT at both baseline and at 3 months. | meters | MEDIAN |
| SECONDARY | Change in 6MWT at 6 Month Visit | Baseline and 6 month follow-up | Of the 27 participants who completed 6-month follow-up in the Placebo + SSA arm, 26 participants completed 6MWT at both baseline and at 6 months. All 26 participants who completed 6-month follow-up in the Xermelo + SSA arm completed the 6MWT at both baseline and 6 months. | meters | MEDIAN |
| SECONDARY | Change in CVHD % Score From Baseline to 3 Month Visit | Baseline and 3 month follow-up | Of the 29 participants who completed 3-month follow-up in the Placebo + SSA arm, 7 completed CVHD evaluations at both baseline and 3 months. In the Xermelo + SSA arm, 5 of the 29 participants who completed 3-month follow-up completed CVHD evaluations at both baseline and 3 months. | Scores on a scale | MEDIAN |
| SECONDARY | Change in CVHD Score From Baseline to 6 Month Visit | Baseline and 6 month follow-up | Of the 27 participants who completed 6-month follow-up in the Placebo + SSA arm, 24 participants completed CVHD evaluations at both baseline and 6 months. In the Xermelo + SSA arm, 23 of the 26 participants who completed 6-month follow-up completed CVHD evaluation at both baseline and at 6 months. The values reported represent the median values for change in CVHD score for each Arm, and do not represent non-meaningful placeholders. | Scores on a scale | MEDIAN |
| SECONDARY | Percentage of Participants With Significant Change in Strain-RV From Baseline at 3 Months | Baseline and 3 month follow-up | Of the 29 participants who completed 3 months follow-up in the Placebo + SSA arm, 3 completed strain RV evaluations at both baseline and 3 months. In the Xermelo + SSA arm, 7 of the 29 participants who completed 3-month follow-up completed strain RV evaluations at both baseline and at 3 months. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Significant Change in Strain-RV From Baseline at 6 Months | Baseline and 6 month follow-up | Of the 27 participants who completed 6-month follow-up in the Placebo + SSA arm, 7 completed strain RV evaluations at both baseline and 6 months. In the Xermelo + SSA arm, 5 of the 26 participants who completed 6-month follow-up completed strain RV evaluations at both baseline and 6 months. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Significant Change in Strain-LV From Baseline at 3 Months | Baseline and 3 month follow-up | Of the 29 participants who completed 3-month follow-up in the Placebo + SSA arm, 7 participants completed strain LV evaluations at both baseline and 3 months. In the Xermelo + SSA arm, 7 of the 29 participants who completed 3-month follow-up completed strain LV evaluations at both baseline and 3 months. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Significant Change in Strain-LV From Baseline at 6 Months | Baseline and 6 month follow-up | Percentage of Participants | NUMBER | |
| SECONDARY | Percentage of Participants With Normal TAPSE at 3 Months | 3 month follow-up | Among 29 who completed 3 months follow-up in the Placebo + SSA arm, 5 participants completed TAPSE evaluations at both baseline and at 3 months. In the Xermelo + SSA arm, 7 of the 29 participants who completed TAPSE evaluations at both baseline and at 3 months. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Normal TAPSE at 6 Months | 6 month follow-up | Of the 27 participants who completed 6-month follow-up in the Placebo + SSA arm, 21 completed TAPSE evaluations at both baseline and 6 months. In Xermelo + SSA arm, 20 of the 26 who completed 6-month follow-up ccompleted TAPSE evaluation at both baseline and 6 months. | Percentage of Participants | NUMBER |
| SECONDARY | Change in 5HIAA From Baseline to 3 Months | Baseline and 3 month follow-up | Of the 29 participants who completed 3-month follow-up in the Placebo + SSA arm, 26 completed 5HIAA evaluations at both baseline and 3 months. In Xermelo + SSA arm, all 29 who completed 3-month follow-up completed 5HIAA evaluations at both baseline and 3 months. | ng/mL | MEDIAN |
| SECONDARY | Change in 5HIAA From Baseline to 6 Months | Baseline and 6 month follow-up | ng/mL | MEDIAN | |
| SECONDARY | Change in Troponin From Baseline to 3 Months | Baseline and 3 months follow-up | Of the 29 participants who completed 3-month follow-up in the Placebo + SSA arm, 25 completed troponin evaluation at both baseline and 3 months. In the Xermelo + SSA arm, 25 of the 29 who completed 3-month completed troponin evaluation at both baseline and 3 months. | ng/L | MEDIAN |
| SECONDARY | Change in Troponin From Baseline to 6 Months | Baseline and 6 months follow-up | Of the 27 participants who completed 6-month follow-up in the Placebo + SSA arm, 26 completed troponin evaluation at both baseline and 6 months. In the Xermelo + SSA arm, 25 of the 26 who completed 6-month follow-up completed troponin evaluation at both baseline and at 6 months. | ng/L | MEDIAN |
| SECONDARY | Change in MDASI Mean Core Symptom Score From Baseline to 3 Months | Baseline and 3 months follow-up | Of the 29 participants who completed 3-month follow-up in the Placebo + SSA arm, 27 completed MDASI core symptom evaluation at both baseline and 3 months. In the Xermelo + SSA arm, 28 of the 29 participants who completed 3-month follow-up completed MDASI core symptom evaluation at both baseline and 3 months. | Scores on a scale | MEDIAN |
| SECONDARY | Change in Core Symptom Score From Baseline to 6 Months | Baseline and 6 months follow-up | All 27 participants who completed 6-month follow-up in the Placebo + SSA arm completed MDASI core symptom evaluation at both baseline and 6 months. In the Xermelo + SSA arm, 25 of the 26 participants who completed 6-month follow-up completed MDASI core symptom evaluation at both baseline and 6 months. | Scores on a scale | MEDIAN |
| SECONDARY | Change in MDASI Mean Total Symptom Score From Baseline to 3 Months | Baseline and 3 months follow-up | Of the 29 participants who completed 3-month follow-up in the Placebo + SSA arm, 27 completed MDASI total symptom evaluation at both baseline and 3 months. In the Xermelo + SSA arm, all 28 participants who completed 3-month follow-up completed MDASI total symptom evaluation at both baseline and 3 months. | points | MEDIAN |
| SECONDARY | Change in MDASI Mean Total Symptom Score From Baseline to 6 Months | Baseline and 6 months follow-up | All 27 participants who completed 6-month follow-up in the Placebo + SSA arm completed MDASI total symptom evaluation at both baseline and 6 months. In the Xermelo + SSA arm, 25 of the 26 participants who completed 6-month follow-up completed MDASI total symptom evaluation at both baseline and 6 months. | Scores on a scale | MEDIAN |
| SECONDARY | Change in MDASI Mean Interference Score From Baseline to 3 Months | Baseline and 3 months follow-up | Of the 29 participants who completed 3-month follow-up in the Placebo + SSA arm, 26 completed MDASI interference evaluation at both baseline and 3 months. In the Xermelo + SSA arm, 28 of the 29 participants who completed 3-month follow-up completed MDASI interference evaluation at both baseline and 3 months. | Scores on a scale | MEDIAN |
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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