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Sub-Q Versus IV Furosemide in Acute Heart Failure

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ClinicalTrials.gov Identifier: NCT02579057
Recruitment Status : Completed
First Posted : October 19, 2015
Results First Posted : November 17, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
scPharmaceuticals, Inc.
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Furosemide Injection Solution (SCP-101) Drug: Furosemide Injection Solution, USP Phase 2 Phase 3

Detailed Description:

The prevalence of chronic heart failure is increasing, and despite advances in the treatment of chronic heart failure, in-hospital mortality and readmission are high. Heart failure costs the US about 32 billion per year, and a large percentage of the costs are due to hospitalizations. Most clinicians would agree that patients with decompensated heart failure presenting with hypotension, worsening renal function and altered mental status should be hospitalized. However, there is a subset of patients presenting with dyspnea and edema due to volume overload that necessitate rapid symptom improvement but are hemodynamically stable. Oral diuretics would likely be ineffective but hospital admission for IV diuretics seems excessive.

The research hypothesis is that subcutaneously administered furosemide will be an effective alternative to IV furosemide for hemodynamically stable chronic heart failure patients presenting with volume overload in the ambulatory setting. Patients will be randomized to receive Furosemide Injection, USP intravenously or Furosemide Injection Solution (SCP-101) delivered subcutaneously. The IV patients will get the usual care of the heart failure clinic, which includes having an IV placed and delivery of a one-time dose of IV furosemide with the dose determined by the providers (maximum dose 160mg IV). The subcutaneous patients will receive 80mg of Furosemide Injection Solution (SCP-101) administered subcutaneously over 5 hours (30mg in first hour and 12.5mg/hour for 4 hours).

Both groups of patients will be observed for 6 hours to assess diuresis. Patients will be asked to fill out a survey about their symptom improvement (Kansas City Cardiomyopathy questionnaire) and overall satisfaction related to the treatment experience. They will also be monitored for side effects including ototoxicity and discomfort at the access site (burning, itching, and pain). Electrolytes and renal function will be checked once after the patients receive diuretic therapy.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Parallel-Group Pilot Study Comparing IV Furosemide to Subcutaneous Furosemide in Acute Decompensated Heart Failure Patients
Actual Study Start Date : February 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Furosemide

Arm Intervention/treatment
Active Comparator: Furosemide Injection Solution, USP
Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment)
Drug: Furosemide Injection Solution, USP
Other Name: IV furosemide

Experimental: Furosemide Injection Solution (SCP-101)
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)
Other Name: sc Furosemide




Primary Outcome Measures :
  1. Urine Output [ Time Frame: 6-hour period ]
    The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.


Secondary Outcome Measures :
  1. Heart Failure Symptom Scoring/Symptom Improvement [ Time Frame: 6-hour period ]
    Will evaluate if subjective heart failure symptoms improve over the period of diuresis. Measured by Kansas City Cardiomyopathy Questionnaire

  2. Number of Participants With Side Effects [ Time Frame: Up to 6 hours ]
    Cumulative total of pain, local skin reactions (including hematoma and induration) and electrolyte abnormalities.

  3. Urine Sodium [ Time Frame: 6-hour period ]
    Total urinary sodium produced during the 6 hour urine collection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579057


Locations
United States, Maryland
Johns Hopkins Hospital Heart Failure Bridge Clinic
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
scPharmaceuticals, Inc.
Investigators
Principal Investigator: Stuart Russell, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02579057     History of Changes
Other Study ID Numbers: IRB00068019
First Posted: October 19, 2015    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: December 18, 2017
Last Verified: November 2017

Keywords provided by Johns Hopkins University:
Congestive heart failure
Furosemide

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pharmaceutical Solutions
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action