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

The purpose of the OUTPATIENT-WHF study is to characterize the effectiveness of outpatient intravenous diuretic therapy as a treatment for worsening heart failure.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure
• Intervention / Treatment: Other: Initial outpatient management strategy, including outpatient IV diuretics in clinic; Other: Initial hospitalization-based management strategy

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; Management strategy including IV diuretic in the outpatient clinic
Other: Initial hospitalization-based management strategy	Other: Initial hospitalization-based management strategy; Direct admission to the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Days alive and out of hospital	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death		30 days
Death		90 days
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
Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index	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).	30 days
Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)	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.	30 days
Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index	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).	90 days
Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)	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.	90 days

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Stephen Greene, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Physiological Effects of Drugs; Natriuretic Agents; Diuretics
• Other Study ID Numbers: Pro00111091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No