Heart Failure
Conditions
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.
Interventions
OTHERInitial outpatient management strategy, including outpatient IV diuretics in clinic
Management strategy including IV diuretic in the outpatient clinic
OTHERInitial hospitalization-based management strategy
Direct admission to the hospital
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days alive and out of hospital | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total hospitalizations | 30 days | — |
| Total emergency department visits | 30 days | — |
| Days alive and out of hospital | 90 days | — |
| Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index | 30 days | 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) | 30 days | 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. |
| Death | 30 days | — |
Countries
United States
Outcome results
None listed