Heart FailureNCT05704595
Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
A study testing Initial outpatient management strategy, including outpatient IV diuretics in clinic and Initial hospitalization-based management strategy in people with Heart Failure, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Initial outpatient management strategy, including outpatient IV diuretics in clinic and Initial hospitalization-based management strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of the OUTPATIENT-WHF study is to characterize the effectiveness of outpatient intravenous diuretic therapy as a treatment for worsening heart failure.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Initial outpatient management strategy, including outpatient IV diuretics in clinic, Initial hospitalization-based management strategy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial outpatient management strategy, including outpatient IV diuretics in clinicOther
Management strategy including IV diuretic in the outpatient clinic
Initial hospitalization-based management strategyOther
Direct admission to the hospital
| Study group | Role | What they receive |
|---|---|---|
| Initial outpatient management strategy, including outpatient IV diuretics in clinic | Other | Not described Receives: Other: Initial outpatient management strategy, including outpatient IV diuretics in clinic |
| Initial hospitalization-based management strategy | Other | Not described Receives: Other: Initial hospitalization-based management strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive and out of hospital
Measured: 30 days
Secondary outcomes (11)
Days alive and out of hospital
Measured: 90 days
Total hospitalizations
Measured: 30 days
Total hospitalizations
Measured: 90 days
Total emergency department visits
Measured: 30 days
Total emergency department visits
Measured: 90 days
Death
Measured: 30 days
Death
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start27 Mar 2023
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Why it stopped: Study no longer moving forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Greene, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704595
- Sponsor's protocol ID
- Pro00111091
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
- ClinicalTrials.gov ID
- NCT05704595
- Acronym / sponsor ID
- Pro00111091
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study no longer moving forward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial outpatient management strategy, including outpatient IV diuretics in clinicManagement strategy including IV diuretic in the outpatient clinic | Other | Initial outpatient management strategy, including outpatient IV diuretics in clinic |
| Initial hospitalization-based management strategyDirect admission to the hospital | Other | Initial hospitalization-based management strategy |
Primary outcome
Days alive and out of hospital
Time frame: 30 days
11 secondary outcomes
Days alive and out of hospital
Time frame: 90 days
Total hospitalizations
Time frame: 30 days
Total hospitalizations
Time frame: 90 days
Total emergency department visits
Time frame: 30 days
Total emergency department visits
Time frame: 90 days
Death
Time frame: 30 days
Death
Time frame: 90 days
Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index
Time frame: 30 days
Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)
Time frame: 30 days
Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index
Time frame: 90 days
Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS)
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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A Study of Bimagrumab in Participants With HFpEF
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Greene principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial outpatient management strategy, including outpatient IV diuretics in clinic and Initial hospitalization-based management strategy in people with Heart Failure, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive and out of hospital (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.