Sub-Q Versus IV Furosemide in Acute Heart Failure

Last updated: November 20, 2017
Sponsor: Johns Hopkins University
Overall Status: Completed

Phase

2/3

Condition

Cardiovascular Disease

Chest Pain

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT02579057
IRB00068019
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • An Institutional Review Board (IRB) approved informed consent is signed and datedprior 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 recenthospitalization 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 complywith all study procedures

Exclusion

Exclusion Criteria:

  • Presenting with symptoms where it is anticipated that there is a high chance ofhospitalization such as ischemia, uncontrolled arrhythmia, infection, hemodynamicinstability (elevated or low blood pressure), respiratory compromise, or electrolyteabnormalities (>25% increase in creatinine from baseline, potassium, hyponatremia).

  • On experimental medication or currently participating in a cardiovascular researchstudy.

  • Presence or need for urinary catheterization, urinary tract abnormality or disorderinterfering with urination

  • Any surgical or medical condition which in the opinion of the investigator mayinterfere with participation in the study or which may affect the outcome of the study

  • Inability to comply with study requirements

Study Design

Total Participants: 40
Study Start date:
February 01, 2016
Estimated Completion Date:
July 31, 2017

Study 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.

Connect with a study center

  • Johns Hopkins Hospital Heart Failure Bridge Clinic

    Baltimore, Maryland 21287
    United States

    Site Not Available

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