Sub-Q Versus IV Furosemide in Acute Heart Failure

NCT02579057 | Completed Phase 2 Results

• 1 other identifier: IRB00068019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the clinical efficacy of subcutaneously administered Furosemide Injection Solution versus intravenous administration of Furosemide Injection, United States Pharmacopeia (USP) in adult patients presenting to a heart failure clinic with decompensated heart failure. Half of the patients will receive a subcutaneously administered Furosemide Injection Solution; the other half will receive an intravenous administration of Furosemide Injection.

Conditions

Congestive Heart Failure

Keywords

Congestive heart failure; Furosemide

Outcome Measures

Primary Outcomes (1)

• Urine Output

  The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.

  6-hour period

Secondary Outcomes (3)

• Heart Failure Symptom Scoring/Symptom Improvement

  6-hour period

• Number of Participants With Side Effects

  Up to 6 hours

• Urine Sodium

  6-hour period

Study Arms (2)

Furosemide Injection Solution, USP

ACTIVE COMPARATOR

Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)

Drug: Furosemide Injection Solution, USP

Furosemide Injection Solution (SCP-101)

EXPERIMENTAL

80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment)

Drug: Furosemide Injection Solution (SCP-101)

Interventions

Furosemide Injection Solution (SCP-101) DRUG

Also known as: sc Furosemide

Furosemide Injection Solution (SCP-101)

Furosemide Injection Solution, USP DRUG

Also known as: IV furosemide

Furosemide Injection Solution, USP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
• Male and female subjects \> 18 years of age
• History of at least 3 months treated heart failure (NYHA class II/III/IV), or recent hospitalization for heart failure; presenting to Heart Failure Bridge Clinic (HFBC) with decompensated heart failure symptoms including elevated jugular venous pressure, dyspnea and peripheral edema where the decision is made to give IV diuretics
• Able to participate in the study in the opinion of the investigator
• Has the ability to understand the requirements of the study and is willing to comply with all study procedures

You may not qualify if:

• Presenting with symptoms where it is anticipated that there is a high chance of hospitalization such as ischemia, uncontrolled arrhythmia, infection, hemodynamic instability (elevated or low blood pressure), respiratory compromise, or electrolyte abnormalities (\>25% increase in creatinine from baseline, potassium, hyponatremia).
• On experimental medication or currently participating in a cardiovascular research study.
• Presence or need for urinary catheterization, urinary tract abnormality or disorder interfering with urination
• Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study
• Inability to comply with study requirements

Sponsors & Collaborators

• Johns Hopkins University: lead
• scPharmaceuticals, Inc.: collaborator

Study Sites (1)

Johns Hopkins Hospital Heart Failure Bridge Clinic

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Gilotra NA, Princewill O, Marino B, Okwuosa IS, Chasler J, Almansa J, Cummings A, Rhodes P, Chambers J, Cuomo K, Russell SD. Efficacy of Intravenous Furosemide Versus a Novel, pH-Neutral Furosemide Formulation Administered Subcutaneously in Outpatients With Worsening Heart Failure. JACC Heart Fail. 2018 Jan;6(1):65-70. doi: 10.1016/j.jchf.2017.10.001. Epub 2017 Dec 6.

  PMID: 29226816 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Limitations and Caveats

This was a phase II exploratory trial with a small sample size

Results Point of Contact

• Title: Stuart Russell MD
• Organization: Johns Hopkins Hospital

srusse14@jhmi.edu

4109555708

Study Officials

• Stuart Russell, MD

  Johns Hopkins University

  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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 19, 2015
• Study Start: February 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 18, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-11

Locations

US (1)