Heart Failure Clinical Trial

Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot

Summary

The Pilot study is designed to evaluate the overall safety and feasibility of a strategy based on subcutaneous delivery of furosemide. It will be used to inform the subsequent evaluation phase of the study (separate protocol). The primary objective of the study is to determine if a strategy of a novel subcutaneous delivery of furosemide is safe and feasible in patients with acute heart failure.

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Full Description

Multi-center, open-label, pilot study conducted in 2 phases. Each phase will enroll 20 subjects that will be used to inform the study design of the SUBQ-HF Study (approximately 300 evaluable patients randomized to either usual inpatient care or early discharge with home subcutaneous furosemide for 1-7 days).

Inpatient Pilot Phase:

Eligible in-patients will be approached for participation. Subjects who consent for participation will be treated with subcutaneous furosemide for 48 hours, during which they will remain in the hospital. This will be primarily a safety and feasibility assessment. There will be no formal hypothesis tested, and statistical analysis will be descriptive in nature.

Outpatient Pilot Phase:

Eligible in-patients who are nearing discharge will be approached for participation. Subjects who consent for participation will be instructed on use of device, discharged to home and treated at home with subcutaneous furosemide for 1-7 days. This will be primarily a safety and feasibility assessment. There will be no formal hypothesis tested, and statistical analysis will be descriptive in nature.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age >18 years
Willingness and ability to provide informed consent
Hospitalization for acute heart failure (AHF) with at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography, Brain Natriuretic Peptide > 250 ng/mL or N-terminal pro-brain natriuretic peptide (NTproBNP) > 1000 ng/mL) of congestion

Persistent congestion despite at least 18 hours of intravenous (IV) therapy, defined by the presence of at least 2 or more of the following at the time of consent:

Peripheral edema
Rales
Elevated jugular venous pressure (JVP)
Ascites
BNP > 250 ng/mL or NTproBNP > 1000 ng/mL
Total anticipated daily IV furosemide dose (at time of screening) >80-200 mg (or equivalent)/day
Anticipated need for at least 24 more hours of parenteral diuretic therapy -

Exclusion Criteria:

Severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)< 30 ml/min/1.73m2)
Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
Clinically significant electrical instability during hospitalization
Ongoing need for other intravenous therapies beyond diuretics (vasodilators, antibiotics, etc.)
Anticipated need for ongoing parenteral electrolyte repletion
Planned discharge to location other than home (e.g, hospice, skilled nursing facility, etc.)
Anticipated cardiac transplantation or left ventricular assist device within the next 30 days
Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
Known or anticipated pregnancy in the next 30 days Prior use of subcutaneous furosemide pump or current use of any subcutaneous pump, on-body infusion devices or patients who give regimented injections at the intended site of the furosemide infusion device
Other psychosocial or physical barriers to following the protocol and using a subcutaneous pump device outside the hospital setting
Unable to accurately measure urine output
Known allergy to furosemide
Known sensitivity or allergy to medical adhesive tape

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

40

Study ID:

NCT02877095

Recruitment Status:

Completed

Sponsor:

Adrian Hernandez

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There are 5 Locations for this study

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Emory University Hospital
Atlanta Georgia, 30322, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Metro Health System
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

40

Study ID:

NCT02877095

Recruitment Status:

Completed

Sponsor:


Adrian Hernandez

How clear is this clinincal trial information?

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