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NCT03458325 · ClinicalTrials.gov registry record · Phase 3

Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure

A Phase 3 study of Heart Failure, sponsored by scPharmaceuticals.

Completed
Registry status
Phase 3
Development phase
27
Enrollment target
8
Study locations

NCT03458325: Completed Phase 3 study of Heart Failure, sponsored by scPharmaceuticals.

NCT03458325 is a Phase 3 study of Heart Failure that has completed, run by scPharmaceuticals. The registered enrollment target is 27 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03458325, a Phase 3 study of Heart Failure, has completed, sponsored by scPharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
27 participants
Enrollment target
8
Study locations

Study Summary

The study is to evaluate the safe admission avoidance and the overall economic impact associated with management of worsening HF using the drug-device combination product, the Furoscix Infusor, outside the hospital setting in patients initially presenting to the emergency department. 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 evaluate differences in healthcare resource utilization and direct medical costs for patients treated with the Furoscix Infusor outside the hospital versus patients receiving intravenous furosemide for ≤ 72 hours in the hospital setting for 30 days post-discharge from the emergency department. 2. To evaluate the safety of Furoscix administered outside the hospital. 3. To evaluate and describe quality of life and patient satisfaction for patients who receive the Furoscix Infusor outside the hospital setting.

Conditions Studied

Interventions

  • COMBINATION_PRODUCT Furoscix Infusor

Study Locations (8)

California

  • Olive View - UCLA Medical Center - Sylmar

Connecticut

  • Bridgeport Hospital - Bridgeport

Florida

  • Tampa General Hospital - Tampa

Indiana

  • Ascension St. Vincent Heart Center - Indianapolis

Iowa

  • Unity Point Health - Des Moines

Minnesota

  • University of Minnesota Medical Center - Minneapolis

North Carolina

  • Moses H. Cone Memorial Hospital - Greensboro

Pennsylvania

  • Abington Hospital - Jefferson Health - Abington

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2020-11-12
Est. Completion 2021-06-24
Phase Phase 3

Sponsor

scPharmaceuticals

5 total trials

What the Registry Record Tells You About NCT03458325

The ClinicalTrials.gov registry entry for NCT03458325 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The listed sponsor is scPharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Furoscix Infusor is the first listed.

NCT03458325 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Connecticut, Florida.

Frequently Asked Questions

What is clinical trial NCT03458325 about?

NCT03458325 is a clinical study titled "Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure". The study is to evaluate the safe admission avoidance and the overall economic impact associated with management of worsening HF using the drug-device combination product, the Furoscix Infusor, outside the hospital setting in patients initially presenting to the emergency department. The study drug...

What is the current status of trial NCT03458325?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2020-11-12. Estimated completion is 2021-06-24.

What conditions does trial NCT03458325 study?

This clinical trial studies the following conditions: Heart Failure.

What interventions are being tested in trial NCT03458325?

The interventions under investigation include: Furoscix Infusor (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT03458325?

This trial is sponsored by scPharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03458325 being conducted?

This trial has 8 study locations across California, Connecticut, Florida, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.