MedTrace Logo

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

NCT04593823 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-08-01

Study results available
· View outcomes & findings →

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • scPharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Marvin A Konstam, MD · Principal Investigator

  • James E Udelson, MD · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2022-04-18
Completion
2022-04-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04593823 on ClinicalTrials.gov