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

NCT04593823 | Completed Phase 2 Results FDA Drug

• 1 other identifier: scP-01-008
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 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. 1.To provide pilot data on the effectiveness and safety to inform a pivotal trial.
2. 2.To inform population enrichment strategies
3. 3.To refine pivotal trial endpoints and analytical methods
4. 4.To identify operational challenges of study design
5. 5.To assess patient adherence, competence, and experience
6. 6.To familiarize staff and patients with device application and use

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (5)

• 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

• Number of Cardiovascular Deaths

  Total number of CV deaths between two groups

  Baseline, 30 Days

• Number of Heart Failure Hospitalizations

  Heart Failure hospitalizations compared between two groups

  30 Days

• 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

• NT-proBNP Change From Baseline

  Percentage change in NT-proBNP from baseline at Day 7 compared between two groups

  30 Days

Secondary Outcomes (11)

• Number of Heart Failure Event Free Survival Days

  30 Days

• Number of Subjects Deceased or HF Event Occurred

  30 Days

• Visual Analog Scale (VAS)

  Baseline, 7 Days, 30 Days

• Composite Congestion Score (CCS)

  Baseline, Day 7, Day 30

• 5-Point Current Dyspnea Score

  Baseline, Day 7, Day 30

Study Arms (2)

Furoscix Infusor

EXPERIMENTAL

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).

Combination Product: Furoscix Infusor

Continued Medical Therapy

NO INTERVENTION

The subjects enrolled in this arm will receive treatment as usual

Interventions

Furoscix Infusor 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.

Furoscix Infusor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Diagnosis of symptomatic chronic heart failure (NYHA Class II-IV) with background loop diuretic therapy for at least 4 weeks.
• Need for augmented diuresis outside of the acute care setting as determined by the investigator.
• On background therapy including daily total furosemide equivalent dose (40-160 mg) of loop diuretic or equivalent.
• The subject must have signs of volume expansion, defined as two or more of the following six signs:
• jugular venous distention
• edema (≥ 1+)
• ascites
• pulmonary congestion on chest x-ray
• pulmonary rales
• 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)
• Increase over the preceding 30 days in at least one of the following symptoms characteristic of worsening heart failure:
• dyspnea
• fatigue
• exercise intolerance

You may not qualify if:

• Suspected high risk clinical instability with outpatient treatment.
• Presence of a complicating condition, other than heart failure likely to require hospitalization in next 30 days.
• Pregnant women or women of childbearing age who are not willing to use an adequate form of contraception.
• Known allergy to the active and inactive ingredients of the study medication or device adhesive.
• On experimental medication or currently participating in another interventional research study.
• eGFR \< 20
• Serum potassium at baseline \> 5.4 or \< 3.6
• Concomitant infection
• Heart rate \> 110
• Received IV furosemide or bumetanide within last 24 hours

Sponsors & Collaborators

• scPharmaceuticals, Inc.: lead

Study Sites (18)

Heart Group of Eastern Shore

Fairhope, Alabama, 36532, United States

Location

The Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Aventura Clinical Research, LLC

Aventura, Florida, 33541, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Elite Cardiac Research

Hialeah, Florida, 33012, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Cardiology Consultants

Pensacola, Florida, 32501, United States

Location

James A. Haley Veerans Hospital

Tampa, Florida, 33612, United States

Location

University Hospital - Augusta

Augusta, Georgia, 30901, United States

Location

Advocate Health and Hospitals

Downers Grove, Illinois, 60515, United States

Location

UnityPoint Health - Methodist Hospital

Peoria, Illinois, 61606, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cone Health Medical Group

Greensboro, North Carolina, 27455, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 39269392 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. John Mohr, PharmD; Sr VP Clinical Development and Medical Affairs
• Organization: scPharmaceuticals

jmohr@scpharma.com

7813017220

Study Officials

• Marvin A Konstam, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

• James E Udelson, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 20, 2020
• Study Start: May 3, 2021
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)