Back to resultsEffectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Initial outpatient management strategy, including outpatient IV diuretics in clinic
Initial hospitalization-based management strategy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria: ≥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 Exclusion Criteria: 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
Sites / Locations
- Duke University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Initial outpatient management strategy, including outpatient IV diuretics in clinic
Initial hospitalization-based management strategy
Arm Description
Outcomes
Primary Outcome Measures
Days alive and out of hospital
Secondary Outcome Measures
Days alive and out of hospital
Total hospitalizations
Total hospitalizations
Total emergency department visits
Total emergency department visits
Death
Death
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).
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.
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05704595
Brief Title
Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
Official Title
Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Initial outpatient management strategy, including outpatient IV diuretics in clinic
Arm Type
Other
Arm Title
Initial hospitalization-based management strategy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Initial outpatient management strategy, including outpatient IV diuretics in clinic
Intervention Description
Management strategy including IV diuretic in the outpatient clinic
Intervention Type
Other
Intervention Name(s)
Initial hospitalization-based management strategy
Intervention Description
Direct admission to the hospital
Primary Outcome Measure Information:
Title
Days alive and out of hospital
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Days alive and out of hospital
Time Frame
90 days
Title
Total hospitalizations
Time Frame
30 days
Title
Total hospitalizations
Time Frame
90 days
Title
Total emergency department visits
Time Frame
30 days
Title
Total emergency department visits
Time Frame
90 days
Title
Death
Time Frame
30 days
Title
Death
Time Frame
90 days
Title
Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index
Description
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).
Time Frame
30 days
Title
Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)
Description
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.
Time Frame
30 days
Title
Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index
Description
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).
Time Frame
90 days
Title
Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Greene
Phone
919 684 8111
Email
stephen.green@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Greene
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen J Greene
Phone
860-484-9403
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
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