Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05704595 | Recruiting | Heart Failure

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

Duke University

Brief 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.

Condition or disease

Heart Failure

Intervention/treatment

Initial outpatient management strategy, including outpatient IV diuretics in clinic

Initial hospitalization-based management strategy

Phase

Not Applicable

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 70 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
Actual Study Start Date : March 27, 2023
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : May 2025
Arm Intervention/treatment

Other: Initial outpatient management strategy, including outpatient IV diuretics in clinic

Other: Initial outpatient management strategy, including outpatient IV diuretics in clinic

Other: Initial hospitalization-based management strategy

Other: Initial hospitalization-based management strategy
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • ≥18 years of age
  • Presentation to a Duke outpatient clinic with heart failure requiring IV diuretics, as per clinician judgement
  • Able to provide signed informed consent
  • Successful completion of EuroQOL-5 dimensions survey
Exclusion Criteria
  • Managing clinician without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.
  • Patient without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.
  • History of left ventricular assist device or heart transplantation
  • End-stage kidney disease requiring chronic dialysis therapy
  • New diagnosis of heart failure
  • Pregnant or breast-feeding
  • Fever >101.0 degrees Fahrenheit at screening
  • Any other condition that in the judgment of the investigator would jeopardize the patient's compliance with the study protocol
Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)

Location Details

Please Choose a site

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710