Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)

Last updated: April 24, 2025
Sponsor: Duke University
Overall Status: Trial Not Available

Phase

N/A

Condition

Chest Pain

Heart Failure

Hyponatremia

Treatment

Initial hospitalization-based management strategy

Initial outpatient management strategy, including outpatient IV diuretics in clinic

Clinical Study ID

NCT05704595
Pro00111091
  • Ages > 18
  • All Genders

Study Summary

The purpose of the OUTPATIENT-WHF study is to characterize the effectiveness of outpatient intravenous diuretic therapy as a treatment for worsening heart failure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥18 years of age

  2. Presentation to a Duke outpatient clinic with heart failure requiring IV diuretics,as per clinician judgement

  3. Able to provide signed informed consent

  4. Successful completion of EuroQOL-5 dimensions survey

Exclusion

Exclusion Criteria:

  1. Managing clinician without equipoise for initial outpatient treatment strategyversus initial hospitalization-based treatment strategy for heart failure, anddecline to accept randomization.

  2. Patient without equipoise for initial outpatient treatment strategy versus initialhospitalization-based treatment strategy for heart failure, and decline to acceptrandomization.

  3. History of left ventricular assist device or heart transplantation

  4. End-stage kidney disease requiring chronic dialysis therapy

  5. New diagnosis of heart failure

  6. Pregnant or breast-feeding

  7. Fever >101.0 degrees Fahrenheit at screening

  8. Any other condition that in the judgment of the investigator would jeopardize thepatient's compliance with the study protocol

Study Design

Treatment Group(s): 2
Primary Treatment: Initial hospitalization-based management strategy
Phase:
Study Start date:
March 27, 2023
Estimated Completion Date:
May 31, 2025

Study Description

The purpose of this study is to determine whether treating certain patients with worsening heart failure as an outpatient with intravenous and oral medications can work just as well as treating patients in the hospital.

Participants who enter into the study and meet eligibility criteria will be randomly chosen to either get intravenous diuretic like Lasix in the clinic and get outpatient care, versus directly admitted to the hospital to receive intravenous diuretic and normal hospital care.

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

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