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

NCT05704595 | Withdrawn

• 1 other identifier: Pro00111091
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Days alive and out of hospital

  30 days

Secondary Outcomes (11)

• Days alive and out of hospital

  90 days

• Total hospitalizations

  30 days

• Total hospitalizations

  90 days

• Total emergency department visits

  30 days

• Total emergency department visits

  90 days

Study Arms (2)

Initial outpatient management strategy, including outpatient IV diuretics in clinic

OTHER

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

Initial hospitalization-based management strategy

OTHER

Other: Initial hospitalization-based management strategy

Interventions

Initial outpatient management strategy, including outpatient IV diuretics in clinic OTHER

Management strategy including IV diuretic in the outpatient clinic

Initial outpatient management strategy, including outpatient IV diuretics in clinic

Initial hospitalization-based management strategy OTHER

Direct admission to the hospital

Initial hospitalization-based management strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Stephen Greene

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: March 27, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)