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

NCT ID: NCT04593823

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2022-04-18

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Furoscix Infusor

Intervention Type: COMBINATION_PRODUCT

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.

Continued Medical Therapy

The subjects enrolled in this arm will receive treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

scPharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marvin A Konstam, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

James E Udelson, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Heart Group of Eastern Shore

Fairhope, Alabama, United States

The Heart Center Research, LLC

Huntsville, Alabama, United States

Hartford Hospital

Hartford, Connecticut, United States

Aventura Clinical Research, LLC

Aventura, Florida, United States

University of Florida

Gainesville, Florida, United States

Elite Cardiac Research

Hialeah, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Cardiology Consultants

Pensacola, Florida, United States

James A. Haley Veerans Hospital

Tampa, Florida, United States

University Hospital - Augusta

Augusta, Georgia, United States

Advocate Health and Hospitals

Downers Grove, Illinois, United States

UnityPoint Health - Methodist Hospital

Peoria, Illinois, United States

Michigan Heart

Ypsilanti, Michigan, United States

St. Louis Heart and Vascular

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cone Health Medical Group

Greensboro, North Carolina, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

References

Konstam MA, Massaro J, Dhingra R, Walsh M, Ordway L, Pursley MS, McLean DS, Saha S, Close N, Konstam JM, Luepke KH, Mohr JF, Udelson JE. Avoiding Treatment in Hospital With Subcutaneous Furosemide for Worsening Heart Failure: A Pilot Study (AT HOME-HF). JACC Heart Fail. 2024 Nov;12(11):1830-1841. doi: 10.1016/j.jchf.2024.07.015. Epub 2024 Sep 11.

Reference Type: DERIVED

PMID: 39269392 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

scP-01-008

Identifier Type: -

Identifier Source: org_study_id