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

Not Applicable

Withdrawn

• Conditions: Heart Failure
• Interventions: Other: Initial hospitalization-based management strategy; Other: Initial outpatient management strategy, including outpatient IV diuretics in clinic

• Registration Number: NCT05704595
• Lead 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.

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 Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-30
• Study Start: 2023-03-27
• Status Verified: 2025-01
• Primary Completion: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Initial hospitalization-based management strategy	Initial hospitalization-based management strategy	-
Initial outpatient management strategy, including outpatient IV diuretics in clinic	Initial outpatient management strategy, including outpatient IV diuretics in clinic	-

Primary Outcome Measures

Name	Time	Method
Days alive and out of hospital	30 days

Secondary Outcome Measures

Name	Time	Method
Days alive and out of hospital	90 days
Total emergency department visits	90 days
Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index	90 days	The EQ5D utility index consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health).
Death	90 days
Total hospitalizations	90 days
Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)	90 days	The EQ5D VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States