Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study

Heart Failure Clinical Trial

— AT HOME-HF  

Official title:

A Multicenter, Randomized, Open Label, Controlled Study Evaluating the Effectiveness and Safety of Furoscix On-Body Infusor vs Continued Medical Therapy for Worsening Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593823
• Other study ID #: scP-01-008
• Status: Completed
• Phase: Phase 2
• Start date: May 3, 2021
• Est. completion date: April 18, 2022

Study information

• Verified date: July 2023
• Source: scPharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
United States	University Hospital - Augusta	Augusta	Georgia
United States	Aventura Clinical Research, LLC	Aventura	Florida
United States	Advocate Health and Hospitals	Downers Grove	Illinois
United States	Heart Group of Eastern Shore	Fairhope	Alabama
United States	University of Florida	Gainesville	Florida
United States	Cone Health Medical Group	Greensboro	North Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Elite Cardiac Research	Hialeah	Florida
United States	The Heart Center Research, LLC	Huntsville	Alabama
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	University of Wisconsin	Madison	Wisconsin
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Cardiology Consultants	Pensacola	Florida
United States	UnityPoint Health - Methodist Hospital	Peoria	Illinois
United States	St. Louis Heart and Vascular	Saint Louis	Missouri
United States	James A. Haley Veerans Hospital	Tampa	Florida
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
scPharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 7, Day 30
Primary	Number of Cardiovascular Deaths	Total number of CV deaths between two groups	Baseline, 30 Days
Primary	Number of Heart Failure Hospitalizations	Heart Failure hospitalizations compared between two groups	30 Days
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	30 Days
Primary	NT-proBNP Change From Baseline	Percentage change in NT-proBNP from baseline at Day 7 compared between two groups	30 Days
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.	30 Days
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.	30 Days
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.	Baseline, 7 Days, 30 Days
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.	Baseline, Day 7, Day 30
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)	Baseline, Day 7, Day 30
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.	Baseline, Day 3, Day 7, Day 30
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.	Baseline, 7 Days, 30 Days
Secondary	Six-Minute Walk Test (6MWT)	Change from baseline in Six-Minute Walk Test (6MWT) across follow-up timepoints	Baseline, 7 Days, 30 Days
Secondary	Percent Lung Fluid	Lung fluid volume as measured via Remote Dielectric Sensing (ReDS)	Baseline, Day 7, Day 30
Secondary	Body Weight	Body weight of the patient on the day of visit	Baseline, Day 3, Day 7, Day 30
Secondary	Renal Function	Change from baseline in serum creatinine	Baseline, Day 3, Day 7, Day 30