Heart Failure Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Heart Failure

Estimated Enrollment:

70

Study ID:

NCT05704595

Recruitment Status:

Recruiting

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Stephen J Greene
Contact
860-484-9403

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

70

Study ID:

NCT05704595

Recruitment Status:

Recruiting

Sponsor:


Duke University

How clear is this clinincal trial information?

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