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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704595
• Other study ID #: Pro00111091
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Stephen Greene
• Phone: 919 684 8111
• Email: stephen.green[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Initial outpatient management strategy, including outpatient IV diuretics in clinic
Management strategy including IV diuretic in the outpatient clinic
• Initial hospitalization-based management strategy
Direct admission to the hospital

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days alive and out of hospital		30 days
Secondary	Days alive and out of hospital		90 days
Secondary	Total hospitalizations		30 days
Secondary	Total hospitalizations		90 days
Secondary	Total emergency department visits		30 days
Secondary	Total emergency department visits		90 days
Secondary	Death		30 days
Secondary	Death		90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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