Clinical trial NCT05704595: Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
Official title: Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 Criteria:

1. Managing clinician without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.
2. Patient without equipoise for initial outpatient treatment strategy versus initial hospitalization-based treatment strategy for heart failure, and decline to accept randomization.
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 the patient's compliance with the study protocol

Primary outcomes:
measure: Days alive and out of hospital
timeFrame: 30 days
Secondary outcomes:
measure: Days alive and out of hospital
timeFrame: 90 days
measure: Total hospitalizations
timeFrame: 30 days
measure: Total hospitalizations
timeFrame: 90 days
measure: Total emergency department visits
timeFrame: 30 days
measure: Total emergency department visits
timeFrame: 90 days
measure: Death
timeFrame: 30 days
measure: Death
timeFrame: 90 days
measure: Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index
timeFrame: 30 days
measure: Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)
timeFrame: 30 days
measure: Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index
timeFrame: 90 days
measure: Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)
timeFrame: 90 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Stephen Greene
role: PRINCIPAL_INVESTIGATOR
References: