Clincosm LogoSign in Get a demo

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

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05704595
Collaborator
(none)
70
Enrollment
2
Arms
26
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Initial outpatient management strategy, including outpatient IV diuretics in clinic
  • Other: Initial hospitalization-based management strategy
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Outpatient Intravenous Diuretic Therapy for Treatment of Worsening Heart Failure (OUTPATIENT-WHF)
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Days alive and out of hospital [30 days]

Secondary Outcome Measures

  1. Days alive and out of hospital [90 days]

  2. Total hospitalizations [30 days]

  3. Total hospitalizations [90 days]

  4. Total emergency department visits [30 days]

  5. Total emergency department visits [90 days]

  6. Death [30 days]

  7. Death [90 days]

  8. 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).

  9. 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.

  10. Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index [90 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).

  11. Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS) [90 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Stephen Greene, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05704595
Other Study ID Numbers:
  • Pro00111091
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure
Diuretics

Study Results

No Results Posted as of Jan 30, 2023