Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT02877095
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02877095
Study Brief:
Protocol Section:
NCT02877095