Heart Failure
Conditions
Brief summary
This is a multicenter, randomized, open label, controlled study evaluating the effectiveness, and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting. The study drug, Furoscix (furosemide injection 8 mg/ml), is a furosemide solution buffered to a neutral pH containing 80 mg/10 mL for subcutaneous administration over 5 hours via the Furoscix Infusor. The study objectives are: 1. To provide pilot data on the effectiveness and safety to inform a pivotal trial. 2. To inform population enrichment strategies 3. To refine pivotal trial endpoints and analytical methods 4. To identify operational challenges of study design 5. To assess patient adherence, competence, and experience 6. To familiarize staff and patients with device application and use
Detailed description
The purpose of this study is to evaluate the effectiveness and safety of the Furoscix Infusor vs continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of acute care setting. 51 patients will be randomly assigned (2:1) to receive Furoscix vs continued medical therapy. The Treatment Phase comprises a pre-programmed bi-phasic 5-hour drug administration of Furoscix (80 mg/10 mL) via the On-body Infusor. Subjects and/or their caregivers will be trained on device preparation, placement and removal in accordance with product instructions of use (IFU). Subjects should be transitioned back to their oral maintenance diuretic regimen when clinically indicated at the discretion of the investigator. Over the initial 7 days, all subjects will receive daily clinic or phone follow-up by the study staff. Decision of treatment with Furoscix in the intervention arm as well as changes in oral diuretic dosing in the control arm will be determined by the treating physician in coordination with the study nurse. Safety labs will be done on Days 1, 3, 7 and 30. After Subjects have been transitioned to their oral maintenance diuretic regimen, additional doses of Furoscix (for Furoscix group) or IV diuretics (for Treat as Usual group) can be prescribed during the 30-day study period as needed based on the presence of congestion symptoms (e.g. dyspnea, edema, and/or excess weight gain) as determined by the investigator. The Follow-Up Phase will include a visit to the clinic on Day 30 +/- 5 days where effectiveness and safety assessments will be performed including limited physical exam (including NYHA Class), Composite Congestion Score (CCS), 5-point Current Dyspnea Score, 7-point Dyspnea Score, vital signs, laboratory analyses, KCCQ-12, Visual Analog Score (VAS), 6MWT and adverse events.
Interventions
COMBINATION_PRODUCTFuroscix Infusor
Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
Sponsors
scPharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects are eligible for inclusion only if all the following criteria are met: 1. Age 18 years or older. 2. Diagnosis of symptomatic chronic heart failure (NYHA Class II-IV) with background loop diuretic therapy for at least 4 weeks. 3. Need for augmented diuresis outside of the acute care setting as determined by the investigator. 4. On background therapy including daily total furosemide equivalent dose (40-160 mg) of loop diuretic or equivalent. 5. The subject must have signs of volume expansion, defined as two or more of the following six signs: 1. jugular venous distention 2. edema (≥ 1+) 3. ascites 4. pulmonary congestion on chest x-ray 5. pulmonary rales 6. NT-proBNP ≥1000 pg/ml (1400 for patients in atrial fibrillation) or, for patients not on Entresto, BNP ≥200 (400 for patients in atrial fibrillation) 6. Increase over the preceding 30 days in at least one of the following symptoms characteristic of worsening heart failure: 1. dyspnea 2. fatigue 3. exercise intolerance 7. Adequate environment for at home administration of Furoscix by patient or caregiver.
Exclusion criteria
A Subject is not eligible for inclusion if any of the following criteria apply: 1. Suspected high risk clinical instability with outpatient treatment. 2. Presence of a complicating condition, other than heart failure likely to require hospitalization in next 30 days. 3. Pregnant women or women of childbearing age who are not willing to use an adequate form of contraception. 4. Known allergy to the active and inactive ingredients of the study medication or device adhesive. 5. On experimental medication or currently participating in another interventional research study. 6. eGFR \< 20 7. Serum potassium at baseline \> 5.4 or \< 3.6 8. Concomitant infection 9. Heart rate \> 110 10. Received IV furosemide or bumetanide within last 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Cardiovascular Deaths | Baseline, 30 Days | Total number of CV deaths between two groups |
| Number of Heart Failure Hospitalizations | 30 Days | Heart Failure hospitalizations compared between two groups |
| 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 |
| NT-proBNP Change From Baseline | 30 Days | Percentage change in NT-proBNP from baseline at Day 7 compared between two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Six-Minute Walk Test (6MWT) | Baseline, 7 Days, 30 Days | Change from baseline in Six-Minute Walk Test (6MWT) across follow-up timepoints |
| 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. |
| Body Weight | Baseline, Day 3, Day 7, Day 30 | Body weight of the patient on the day of visit |
| Renal Function | Baseline, Day 3, Day 7, Day 30 | Change from baseline in serum creatinine |
| Percent Lung Fluid | Baseline, Day 7, Day 30 | Lung fluid volume as measured via Remote Dielectric Sensing (ReDS) |
| 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. |
| 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. |
| 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. |
| 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) |
Countries
United States
Participant flow
Pre-assignment details
12 Screen Failures
Participants by arm
| Arm | Count |
|---|---|
| Furoscix Infusor Furoscix (furosemide injection, 8 mg/mL) administered subcutaneously over 5 hours via the Furoscix Infusor. The Infusor is applied to the abdomen via a medical grade adhesive and delivers a subcutaneous infusion of Furoscix through a pre-programmed, biphasic delivery profile with 30 mg (3.75 mL) administered over the first hour, followed by 12.5 mg (1.56 mL) per hour for the subsequent 4 hours (Total dose is 80 mg (10 mL) over 5 hours).
Furoscix Infusor: Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours. | 34 |
| Continued Medical Therapy The subjects enrolled in this arm will receive Continued Medical Treatment as usual as per the investigator | 17 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Continued Medical Therapy | Furoscix Infusor |
|---|---|---|---|
| Age, Continuous | 66.0 Years STANDARD_DEVIATION 11.43 | 71.1 Years STANDARD_DEVIATION 11.03 | 63.5 Years STANDARD_DEVIATION 10.91 |
| Body Mass Index | 36.21 kg/m^2 STANDARD_DEVIATION 8.52 | 36.59 kg/m^2 STANDARD_DEVIATION 9.92 | 36.02 kg/m^2 STANDARD_DEVIATION 7.88 |
| Body Weight | 112.28 Kilograms (Kg) STANDARD_DEVIATION 32.99 | 111.70 Kilograms (Kg) STANDARD_DEVIATION 30.7 | 112.56 Kilograms (Kg) STANDARD_DEVIATION 34.52 |
| Daily Furosemide Equivalent Dose | 139.2 mg STANDARD_DEVIATION 132.42 | 124.7 mg STANDARD_DEVIATION 115.01 | 146.7 mg STANDARD_DEVIATION 141.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 17 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| New York Heart Association Class Class I | 0 Participants | 0 Participants | 0 Participants |
| New York Heart Association Class Class II | 6 Participants | 4 Participants | 2 Participants |
| New York Heart Association Class Class III | 43 Participants | 12 Participants | 31 Participants |
| New York Heart Association Class Class IV | 2 Participants | 1 Participants | 1 Participants |
| NT-proBNP | 3276.4 pg/mL STANDARD_DEVIATION 4096.51 | 5467.5 pg/mL STANDARD_DEVIATION 4979.57 | 2249.4 pg/mL STANDARD_DEVIATION 3208.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Female | 15 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 36 Participants | 11 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 34 | 1 / 17 |
| other Total, other adverse events | 23 / 34 | 9 / 17 |
| serious Total, serious adverse events | 12 / 34 | 4 / 17 |
Outcome results
Primary
NT-proBNP Change From Baseline
Percentage change in NT-proBNP from baseline at Day 7 compared between two groups
Time frame: 30 Days
Population: All randomized subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Furoscix Infusor | NT-proBNP Change From Baseline | -7.195 percentage change from baseline (pg/mL) |
| Continued Medical Therapy | NT-proBNP Change From Baseline | -2.170 percentage change from baseline (pg/mL) |
p-value: 0.54795% CI: [-20.01, 37.784]ANOVA
Primary
Number of Cardiovascular Deaths
Total number of CV deaths between two groups
Time frame: Baseline, 30 Days
Population: All randomized subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Furoscix Infusor | Number of Cardiovascular Deaths | Yes | 1 Participants |
| Furoscix Infusor | Number of Cardiovascular Deaths | No | 33 Participants |
| Continued Medical Therapy | Number of Cardiovascular Deaths | No | 17 Participants |
| Continued Medical Therapy | Number of Cardiovascular Deaths | Yes | 0 Participants |
p-value: >0.99995% CI: [-17, 15.9]Chi-squared
Primary
Number of Heart Failure Hospitalizations
Heart Failure hospitalizations compared between two groups
Time frame: 30 Days
Population: All randomized subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Furoscix Infusor | Number of Heart Failure Hospitalizations | No | 29 Participants |
| Furoscix Infusor | Number of Heart Failure Hospitalizations | Yes | 5 Participants |
| Continued Medical Therapy | Number of Heart Failure Hospitalizations | No | 13 Participants |
| Continued Medical Therapy | Number of Heart Failure Hospitalizations | Yes | 4 Participants |
p-value: 0.45995% CI: [-36.4, 13.6]Chi-squared
Primary
Number of Urgent ED/Clinic Visits for Worsening Heart Failure
Urgent ED/Clinic visits for worsening heart failure compared between two groups. Statistical analysis was not performed due to no ED/Clinic visits
Time frame: 30 Days
Population: All randomized subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Furoscix Infusor | Number of Urgent ED/Clinic Visits for Worsening Heart Failure | No | 34 Participants |
| Furoscix Infusor | Number of Urgent ED/Clinic Visits for Worsening Heart Failure | Yes | 0 Participants |
| Continued Medical Therapy | Number of Urgent ED/Clinic Visits for Worsening Heart Failure | No | 17 Participants |
| Continued Medical Therapy | Number of Urgent ED/Clinic Visits for Worsening Heart Failure | Yes | 0 Participants |
Primary
Win Ratio of Composite Endpoint
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.
Time frame: Day 7, Day 30
Population: All randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Furoscix Infusor | Win Ratio of Composite Endpoint | 228 Number of Wins for the group |
| Continued Medical Therapy | Win Ratio of Composite Endpoint | 206 Number of Wins for the group |
95% CI: [0.48, 2.5]
Secondary
5-Point Current Dyspnea Score
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)
Time frame: Baseline, Day 7, Day 30
Population: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furoscix Infusor | 5-Point Current Dyspnea Score | Day 0 | 1.3 score on a scale | Standard Deviation 1 |
| Furoscix Infusor | 5-Point Current Dyspnea Score | Day 7 | 0.8 score on a scale | Standard Deviation 0.9 |
| Furoscix Infusor | 5-Point Current Dyspnea Score | Day 30 | 0.9 score on a scale | Standard Deviation 0.82 |
| Continued Medical Therapy | 5-Point Current Dyspnea Score | Day 0 | 1.8 score on a scale | Standard Deviation 1.15 |
| Continued Medical Therapy | 5-Point Current Dyspnea Score | Day 7 | 1.1 score on a scale | Standard Deviation 0.93 |
| Continued Medical Therapy | 5-Point Current Dyspnea Score | Day 30 | 1.3 score on a scale | Standard Deviation 0.99 |
Secondary
7-Point Dyspnea Score
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.
Time frame: Baseline, Day 3, Day 7, Day 30
Population: All randomized subjects
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Furoscix Infusor | 7-Point Dyspnea Score | Day 7 | Minimally Worse | 0 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 3 | No Change | 8 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 7 | Moderately Worse | 0 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 3 | Moderately Better | 12 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 7 | Markedly Worse | 0 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 3 | Missing | 2 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 7 | Missing | 0 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 3 | Moderately Worse | 0 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 30 | Markedly Better | 6 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 7 | Markedly Better | 4 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 30 | Moderately Better | 13 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 3 | Minimally Better | 8 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 30 | Minimally Better | 6 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 7 | Moderately Better | 13 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 30 | No Change | 5 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 3 | Markedly Worse | 0 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 30 | Minimally Worse | 2 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 7 | Minimally Better | 5 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 30 | Moderately Worse | 1 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 3 | Minimally Worse | 1 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 30 | Markedly Worse | 0 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 7 | No Change | 12 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 30 | Missing | 1 Participants |
| Furoscix Infusor | 7-Point Dyspnea Score | Day 3 | Markedly Better | 3 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 30 | Missing | 3 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 3 | Minimally Better | 4 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 3 | No Change | 8 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 3 | Minimally Worse | 0 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 3 | Moderately Worse | 1 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 3 | Markedly Worse | 1 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 3 | Markedly Better | 1 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 3 | Missing | 2 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 7 | Markedly Better | 2 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 7 | Moderately Better | 3 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 7 | Minimally Better | 4 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 7 | No Change | 6 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 7 | Minimally Worse | 0 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 7 | Moderately Worse | 0 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 7 | Markedly Worse | 0 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 7 | Missing | 2 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 30 | Markedly Better | 0 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 30 | Moderately Better | 5 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 30 | Minimally Better | 3 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 30 | No Change | 6 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 30 | Minimally Worse | 0 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 30 | Moderately Worse | 0 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 30 | Markedly Worse | 0 Participants |
| Continued Medical Therapy | 7-Point Dyspnea Score | Day 3 | Moderately Better | 0 Participants |
Secondary
Body Weight
Body weight of the patient on the day of visit
Time frame: Baseline, Day 3, Day 7, Day 30
Population: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furoscix Infusor | Body Weight | Day 0 | 112.563 Kilograms | Standard Deviation 34.516 |
| Furoscix Infusor | Body Weight | Day 3 | 110.748 Kilograms | Standard Deviation 34.59 |
| Furoscix Infusor | Body Weight | Day 7 | 109.935 Kilograms | Standard Deviation 33.996 |
| Furoscix Infusor | Body Weight | Day 30 | 110.357 Kilograms | Standard Deviation 35.201 |
| Continued Medical Therapy | Body Weight | Day 30 | 117.422 Kilograms | Standard Deviation 30.879 |
| Continued Medical Therapy | Body Weight | Day 0 | 111.704 Kilograms | Standard Deviation 30.697 |
| Continued Medical Therapy | Body Weight | Day 7 | 116.199 Kilograms | Standard Deviation 28.781 |
| Continued Medical Therapy | Body Weight | Day 3 | 115.524 Kilograms | Standard Deviation 30.942 |
Secondary
Composite Congestion Score (CCS)
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.
Time frame: Baseline, Day 7, Day 30
Population: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furoscix Infusor | Composite Congestion Score (CCS) | Day 0 | 3.9 score on a scale | Standard Deviation 1.58 |
| Furoscix Infusor | Composite Congestion Score (CCS) | Day 7 | 2.2 score on a scale | Standard Deviation 2.18 |
| Furoscix Infusor | Composite Congestion Score (CCS) | Day 30 | 1.5 score on a scale | Standard Deviation 1.75 |
| Continued Medical Therapy | Composite Congestion Score (CCS) | Day 0 | 3.7 score on a scale | Standard Deviation 1.72 |
| Continued Medical Therapy | Composite Congestion Score (CCS) | Day 7 | 2.6 score on a scale | Standard Deviation 1.79 |
| Continued Medical Therapy | Composite Congestion Score (CCS) | Day 30 | 2.1 score on a scale | Standard Deviation 2.52 |
Secondary
KCCQ-12 Summary Score
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.
Time frame: Baseline, 7 Days, 30 Days
Population: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furoscix Infusor | KCCQ-12 Summary Score | Baseline | 40.96 units on a scale | Standard Deviation 18.296 |
| Furoscix Infusor | KCCQ-12 Summary Score | Day 7 | 51.55 units on a scale | Standard Deviation 20.388 |
| Furoscix Infusor | KCCQ-12 Summary Score | Day 30 | 55.80 units on a scale | Standard Deviation 24.48 |
| Continued Medical Therapy | KCCQ-12 Summary Score | Baseline | 30.54 units on a scale | Standard Deviation 25.395 |
| Continued Medical Therapy | KCCQ-12 Summary Score | Day 7 | 36.68 units on a scale | Standard Deviation 24.074 |
| Continued Medical Therapy | KCCQ-12 Summary Score | Day 30 | 45.33 units on a scale | Standard Deviation 28.624 |
Secondary
Number of Heart Failure Event Free Survival Days
Out of 30 days, HF event-free survival is the average number of days subjects survived outside the hospital event-free.
Time frame: 30 Days
Population: All randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Furoscix Infusor | Number of Heart Failure Event Free Survival Days | 23.2 days | Standard Deviation 4.79 |
| Continued Medical Therapy | Number of Heart Failure Event Free Survival Days | 14.3 days | Standard Deviation 10.14 |
p-value: 0.336Wilcoxon (Mann-Whitney)
Secondary
Number of Subjects Deceased or HF Event Occurred
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.
Time frame: 30 Days
Population: All randomized subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Furoscix Infusor | Number of Subjects Deceased or HF Event Occurred | No | 28 Participants |
| Furoscix Infusor | Number of Subjects Deceased or HF Event Occurred | Yes | 6 Participants |
| Continued Medical Therapy | Number of Subjects Deceased or HF Event Occurred | No | 13 Participants |
| Continued Medical Therapy | Number of Subjects Deceased or HF Event Occurred | Yes | 4 Participants |
Secondary
Percent Lung Fluid
Lung fluid volume as measured via Remote Dielectric Sensing (ReDS)
Time frame: Baseline, Day 7, Day 30
Population: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furoscix Infusor | Percent Lung Fluid | Day 0 | 36.8 % Fluid Volume in Lungs | Standard Deviation 6.41 |
| Furoscix Infusor | Percent Lung Fluid | Day 30 | 35.6 % Fluid Volume in Lungs | Standard Deviation 6.6 |
| Furoscix Infusor | Percent Lung Fluid | Day 7 | 34.8 % Fluid Volume in Lungs | Standard Deviation 6.09 |
| Continued Medical Therapy | Percent Lung Fluid | Day 7 | 31.3 % Fluid Volume in Lungs | Standard Deviation 6.25 |
| Continued Medical Therapy | Percent Lung Fluid | Day 30 | 34.4 % Fluid Volume in Lungs | Standard Deviation 6.35 |
| Continued Medical Therapy | Percent Lung Fluid | Day 0 | 34.5 % Fluid Volume in Lungs | Standard Deviation 6.7 |
Secondary
Renal Function
Change from baseline in serum creatinine
Time frame: Baseline, Day 3, Day 7, Day 30
Population: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furoscix Infusor | Renal Function | Day 0 | 1.496 mg/dL | Standard Deviation 0.608 |
| Furoscix Infusor | Renal Function | Day 3 | 1.611 mg/dL | Standard Deviation 0.541 |
| Furoscix Infusor | Renal Function | Day 7 | 1.648 mg/dL | Standard Deviation 0.747 |
| Furoscix Infusor | Renal Function | Day 30 | 1.641 mg/dL | Standard Deviation 0.771 |
| Continued Medical Therapy | Renal Function | Day 30 | 2.010 mg/dL | Standard Deviation 1.147 |
| Continued Medical Therapy | Renal Function | Day 0 | 1.696 mg/dL | Standard Deviation 0.747 |
| Continued Medical Therapy | Renal Function | Day 7 | 1.811 mg/dL | Standard Deviation 0.86 |
| Continued Medical Therapy | Renal Function | Day 3 | 1.894 mg/dL | Standard Deviation 0.861 |
Secondary
Six-Minute Walk Test (6MWT)
Change from baseline in Six-Minute Walk Test (6MWT) across follow-up timepoints
Time frame: Baseline, 7 Days, 30 Days
Population: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furoscix Infusor | Six-Minute Walk Test (6MWT) | Baseline | 241.7 meters | Standard Deviation 115.89 |
| Furoscix Infusor | Six-Minute Walk Test (6MWT) | Day 7 | 269.0 meters | Standard Deviation 126.63 |
| Furoscix Infusor | Six-Minute Walk Test (6MWT) | Day 30 | 292.3 meters | Standard Deviation 112.76 |
| Continued Medical Therapy | Six-Minute Walk Test (6MWT) | Baseline | 177.6 meters | Standard Deviation 77.65 |
| Continued Medical Therapy | Six-Minute Walk Test (6MWT) | Day 7 | 201.0 meters | Standard Deviation 85.32 |
| Continued Medical Therapy | Six-Minute Walk Test (6MWT) | Day 30 | 192.3 meters | Standard Deviation 71.17 |
Secondary
Visual Analog Scale (VAS)
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.
Time frame: Baseline, 7 Days, 30 Days
Population: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furoscix Infusor | Visual Analog Scale (VAS) | Day 0 | 57.1 score on a scale | Standard Deviation 18.12 |
| Furoscix Infusor | Visual Analog Scale (VAS) | Day 7 | 66.8 score on a scale | Standard Deviation 16.88 |
| Furoscix Infusor | Visual Analog Scale (VAS) | Day 30 | 70.2 score on a scale | Standard Deviation 18.47 |
| Continued Medical Therapy | Visual Analog Scale (VAS) | Day 0 | 48.8 score on a scale | Standard Deviation 22.12 |
| Continued Medical Therapy | Visual Analog Scale (VAS) | Day 7 | 59.7 score on a scale | Standard Deviation 23.27 |
| Continued Medical Therapy | Visual Analog Scale (VAS) | Day 30 | 60.7 score on a scale | Standard Deviation 24.01 |