Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot

Acute Heart Failure Clinical Trial

— SUBQ-Pilot  

Official title:

Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877095
• Other study ID #: Pro00070399
• Status: Completed
• Phase: Phase 1
• Start date: December 19, 2016
• Est. completion date: November 7, 2017

Study information

• Verified date: November 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 7, 2017
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >18 years

2. Willingness and ability to provide informed consent

3. 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

4. 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

5. Total anticipated daily IV furosemide dose (at time of screening) >80-200 mg (or equivalent)/day

6. Anticipated need for at least 24 more hours of parenteral diuretic therapy -

Exclusion Criteria:

1. Severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)< 30 ml/min/1.73m2)

2. Requirement for inotropes (other than digoxin) or mechanical support during hospitalization

3. Clinically significant electrical instability during hospitalization

4. Ongoing need for other intravenous therapies beyond diuretics (vasodilators, antibiotics, etc.)

5. Anticipated need for ongoing parenteral electrolyte repletion

6. Planned discharge to location other than home (e.g, hospice, skilled nursing facility, etc.)

7. Anticipated cardiac transplantation or left ventricular assist device within the next 30 days

8. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade

9. 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

10. Other psychosocial or physical barriers to following the protocol and using a subcutaneous pump device outside the hospital setting

11. Unable to accurately measure urine output

12. Known allergy to furosemide

13. Known sensitivity or allergy to medical adhesive tape

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Furosemide
subcutaneous furosemide delivered via subcutaneous pump

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Metro Health System	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Adrian Hernandez

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events	The analysis of data from the Pilot Phase will be primarily descriptive in nature and there will be no formal hypothesis testing. Number of patients with events will be reported.	14 days