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Not yet recruitingPhase 3

Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure

Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure: A Cluster-Randomized Crossover Non-Inferiority Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares going home early with furosemide given under the skin to usual hospital care. Furosemide is a medicine that helps remove extra fluid. The study is for adults in the hospital, or planning to stay, for heart failure and measures days alive and out of the hospital over 30 days.

This will be a prospective, cluster-randomized, crossover, non-inferiority trial of 250 participants within 48 hours of an inpatient admission for heart failure or emergency department presentation for heart failure with plans for admission or observation/short-stay hospitalization comparing early discharge using subcutaneous furosemide to standard inpatient care. Individual practice groups will serve as "clusters" and the unit of randomization. Each participating cluster will implement either the early discharge strategy using the intervention or standard care for initial two-month blocks, followed by a crossover to the alternate strategy. The primary outcome is days alive and out of hospital at 30 days.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Within 48 hours of a hospital stay or emergency room visit for heart failure, with plans for admission or a short hospital stay.
  • Expected to need at least 24 more hours of fluid-removing medicine through a vein (IV).
  • Have a home setting where you can safely care for yourself.
  • You or your caregiver can use the device that gives medicine under the skin.

Who can't join

  • Thinking or memory problems that prevent you from understanding and agreeing to join.
  • Where you live makes follow-up visits difficult.
  • Pregnant or breastfeeding.
  • Need more than 250 mg of IV furosemide per day.
  • Very low kidney function: an eGFR test result below 20.
  • A type 1 heart attack, caused by a blocked heart artery, during this hospital stay.
  • Very advanced heart failure with a heart transplant or heart pump (LVAD) received or being considered, or a need for medicine or machines to help the heart pump.
  • Blood potassium below 3.0 or above 6.0 mmol/L, or blood sodium below 125 mmol/L.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age ≥ 18 years * Within 48 hours of inpatient stay OR ED presentation for HF with plans for admission OR observation stay/short-stay hospitalization for HF * Expected to require at least 24 additional hours of IV diuretics * Adequate home environment for self-care * Patient or caregiver capable of operating subcutaneous delivery device Exclusion Criteria: * Cognitive impairment preventing informed consent * Geographic barriers to follow-up * Pregnancy or breastfeeding * IV furosemide requirement \>250mg/day * eGFR \<20 mL/min/1.73m2 * Type 1 myocardial infarction during index admission * End-stage HF with receipt or consideration of heart transplant or LVAD or requiring inotropic or mechanical circulatory support * Potassium \<3.0 or \>6.0 mmol/L or sodium \<125 mmol/L

Study sites (2)

TX