Trial · NCT04593823
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 | Win Ratio of Composite Endpoint | Day 7, Day 30 | Win Ratio calculated as number of pairs of Furoscix On-Body Infusor subject "wins" divided by number of pairs of Furoscix On-Body Infusor subject "losses" when compared to Continued Medical Therapy subjects. Components of Endpoint composite outcome: CV death, HF hospitalization, Urgent ED/Clinic visit at 30 days and percent change in NT-proBNP from baseline at Day 7. See Statistical Analysis Plan for detailed explanation of this statistical method. |
| Primary | Number of Cardiovascular Deaths | Baseline, 30 Days | Total number of CV deaths between two groups |
| Primary | Number of Heart Failure Hospitalizations | 30 Days | Heart Failure hospitalizations compared between two groups |
| Primary | Number of Urgent ED/Clinic Visits for Worsening Heart Failure | 30 Days | Urgent ED/Clinic visits for worsening heart failure compared between two groups. Statistical analysis was not performed due to no ED/Clinic visits |
| Primary | NT-proBNP Change From Baseline | 30 Days | Percentage change in NT-proBNP from baseline at Day 7 compared between two groups |
| Secondary | Number of Heart Failure Event Free Survival Days | 30 Days | Out of 30 days, HF event-free survival is the average number of days subjects survived outside the hospital event-free. |
| Secondary | Number of Subjects Deceased or HF Event Occurred | 30 Days | Subjects that are Deceased or HF event occurred (hospitalization for HF or urgent ED/clinic visits for HF) over 30 days compared between treatment groups. |
| Secondary | Visual Analog Scale (VAS) | Baseline, 7 Days, 30 Days | The patient global assessment VAS is a patient-reported assessment of how good or bad a patient feels their health is on a given day. It is reported on a visual scale of 0 to 100, with 0 being the worst health they can imagine and 100 being the best health they can imagine. |
| Secondary | Composite Congestion Score (CCS) | Baseline, Day 7, Day 30 | The composite congestion score (ccs) is calculated by summing the individual scores for orthopnea, pedal edema and jugular venous distension. The investigator-assessed the signs and symptoms of congestion (orthopnea, pedal edema, and jugular venous distension) on a 4-point grading scale ranging from 0 to 3. Higher score indicates greater severity of symptoms ranging from 0 to 9. |
| Secondary | 5-Point Current Dyspnea Score | Baseline, Day 7, Day 30 | The 5-Point Current Dyspnea Status Questionnaire is a single-item, self-administered instrument that quantifies current symptoms of dyspnea. The scale includes the absence of dyspnea (a score of 1), mild shortness of breath (a score of 2), moderate shortness of breath (a score of 3), severe shortness of breath (a score of 4) and the worst possible shortness of breath (a score of 5) |
| Secondary | 7-Point Dyspnea Score | Baseline, Day 3, Day 7, Day 30 | The 7-Point Dyspnea Status Questionnaire is a single-item, self-administered instrument that quantifies changes in dyspnea symptoms since initiation of study product. The scale ranges from Markedly better, Moderately better, Minimaly better, No change, Minimally worse, Moderately worse to Markedly worse. |
| Secondary | KCCQ-12 Summary Score | Baseline, 7 Days, 30 Days | The KCCQ-12 questionnaire is a patient-reported assessment to capture symptom frequency, physical and social limitations, and quality-of-life impairment as a result of HF, as well as an overall summary score. In the KCCQ-12, responses are given for each individual item is scored on a scale of 0-100 with higher scores indicating better health. |
| Secondary | Six-Minute Walk Test (6MWT) | Baseline, 7 Days, 30 Days | Change from baseline in Six-Minute Walk Test (6MWT) across follow-up timepoints |
| Secondary | Percent Lung Fluid | Baseline, Day 7, Day 30 | Lung fluid volume as measured via Remote Dielectric Sensing (ReDS) |
| Secondary | Body Weight | Baseline, Day 3, Day 7, Day 30 | Body weight of the patient on the day of visit |
| Secondary | Renal Function | Baseline, Day 3, Day 7, Day 30 | Change from baseline in serum creatinine |
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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