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

NCT ID: NCT05704595

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2025-05-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Initial outpatient management strategy, including outpatient IV diuretics in clinic

Group Type: OTHER

Initial outpatient management strategy, including outpatient IV diuretics in clinic

Intervention Type: OTHER

Management strategy including IV diuretic in the outpatient clinic

Initial hospitalization-based management strategy

Group Type: OTHER

Initial hospitalization-based management strategy

Intervention Type: OTHER

Direct admission to the hospital

Interventions

Initial outpatient management strategy, including outpatient IV diuretics in clinic

Management strategy including IV diuretic in the outpatient clinic

Intervention Type: OTHER

Initial hospitalization-based management strategy

Direct admission to the hospital

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Greene

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00111091

Identifier Type: -

Identifier Source: org_study_id