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NCT07018297Not 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

Source: ClinicalTrials.gov · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
250 (estimated)
First submitted
4 Jun 2025
Start date
Aug 2026
Primary completion date
1 Aug 2028
Lead sponsor
University of Texas Southwestern Medical Center
NCT number
NCT07018297

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 250
  • From Aug 2026 to the primary completion date, 1 Aug 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Cognitive impairment preventing informed consent
  • 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

Lab values

  • eGFR \<20 mL/min/1.73m2
  • Potassium \<3.0 or \>6.0 mmol/L or sodium \<125 mmol/L

Other

  • Geographic barriers to follow-up
  • Pregnancy or breastfeeding
  • IV furosemide requirement \>250mg/day

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Texas Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Baylor Scott and White Health System
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.