Heart FailurePhase 3NCT07018297
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
A Phase 3 study testing Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor in people with Heart Failure and Acute Decompensated Heart Failure, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure, Acute Decompensated Heart Failure
- What is being tested?
- Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2028to 1 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75209
Baylor Scott and White Health System
Dallas, Texas, 75246
Neil Keshvani, MD, 214-384-9004, neil.keshvani@bswhealth.org
About this study
Official title: Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure: A Cluster-Randomized Crossover Non-Inferiority Trial
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.
Read the detailed description
HF contributes to over 1 million emergency department visits and nearly 1 million hospitalizations annually. The estimated annual mean cost per person with HF was $32,955 in 2017-2018, with the majority of costs due to hospitalization. The current standard of care typically involves admission for intravenous (IV) diuretics, monitoring for adequate decongestion, transition to oral diuretics, and discharge once clinical stability is achieved. The median length of stay for HF hospitalizations in the United States is 5 days but varies significantly across health systems and at the patient level. Extended hospitalizations, while traditionally considered necessary for complete decongestion, carry substantial risks, including increased risk of all-cause death and readmission. Patients experience deconditioning and increased frailty and are at risk for hospital-acquired complications, including infections, falls, and cognitive decline. Furthermore, prolonged hospitalization can lead to post-hospital syndrome, characterized by increased vulnerability and risk for adverse events in the immediate post-discharge period. For these reasons, reducing length of stay has emerged as a critical goal in HF management, aimed at both decreasing costs and improving patient outcomes by minimizing hospital-related complications and preserving quality of life.
Recent developments in subcutaneous furosemide formulations offer a potential solution to this clinical challenge. Pharmacokinetic studies demonstrate that subcutaneous furosemide achieves bioavailability comparable to IV administration and superior to oral formulations. The consistent absorption profile and reliable bioavailability of subcutaneous furosemide, combined with its ease of administration, presents an opportunity to provide hospital-level diuresis in the outpatient setting. This could enable earlier discharge while maintaining the intensity of diuretic therapy needed for complete decongestion. However, a critical knowledge gap exists regarding the safety and efficacy of an early discharge strategy utilizing subcutaneous furosemide compared to traditional inpatient management.
This trial aims to address this knowledge gap through a cluster-randomized crossover study comparing early discharge with subcutaneous furosemide to standard inpatient care and receipt of IV furosemide. By implementing standardized protocols across two major health systems, the investigators will evaluate whether this novel approach can safely reduce length of stay while maintaining clinical outcomes. The study design accounts for institutional variations in care delivery while providing robust data on safety, efficacy, and resource utilization. Results from this trial could fundamentally change the management paradigm for acute heart failure hospitalizations, potentially improving both healthcare efficiency and patient outcomes.
- Conditions
- Heart Failure, Acute Decompensated Heart Failure
- Being tested
- Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor
- Keywords
- Subcutaneous Furosemide, Length of Stay (LOS), Hospitalization, Resource Allocation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-InfusorCombination product
Also called subcutaneous furosemide
Each practice group randomized to early discharge with subcutaneous furosemide will provide the patient with prefilled units of Lasix® ONYU furosemide injection containing 80 mg per 2.67 mL in a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor that will be used in conjunction with the reusable unit of the Lasix ONYU Infusor. Dosing based on pre-admission oral furosemide requirements: ≤80mg/day oral furosemide will be given 80mg subcutaneous once daily or >80mg/day oral furosemide will be given 80mg subcutaneous twice daily. Dosing will be continued until clinical euvolemia is reached.
| Study group | Role | What they receive |
|---|---|---|
| Early Discharge with Subcutaneous Furosemide | Experimental | The practice group randomized to early discharge with subcutaneous furosemide home infusion will begin initiation of subcutaneous furosemide (LASIX-ONYU) with a SQIN-Infusor device prior to discharge from the hospital. Dosing will be based on pre-admission oral furosemide requirements. Those with a home dose of ≤80mg/day oral furosemide will receive 80mg subcutaneous once daily at home and those with >80mg/day oral furosemide will receive 80mg subcutaneous twice daily at home. Receives: Combination Product: Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor |
| Usual Care | No intervention | Usual inpatient care with IV furosemide. Discharge timing determined by treating physician per standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive and out of the hospital
Days alive and out of the hospital will be ascertained via retrospective review of the electronic health record.
Measured: 30-day
Secondary outcomes (3)
Change in Quality of Life
Longitudinal analysis of Kansas City Cardiomyopathy Overall Summary Scores
Measured: Baseline, 14-day, and 30-day. The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where 0 is worst quality of life and 100 is best quality of life.
Change in N-terminal pro B-type natriuretic peptide
Longitudinal analysis of N-terminal pro B-type natriuretic peptide (NT-proBNP) levels
Measured: Baseline, 14-day, and 30-day
Time-to-event for mortality and readmission
Time-to-event analyses for mortality and readmission outcomes
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study startAug 2028 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomization at the cluster level (hospitalist subgroups, academic teaching teams, and cardiology practice groups). Each participating cluster will implement either the early discharge strategy or standard care for initial two-month blocks, followed by a crossover to the alternate strategy.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ambarish Pandey, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018297
- Sponsor's protocol ID
- STU2025-0766
- Status last verified
- Nov 2026
- First submitted
- 4 Jun 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. No abstract available.
PubMed 37797885Bhatnagar R, Fonarow GC, Heidenreich PA, Ziaeian B. Expenditure on Heart Failure in the United States: The Medical Expenditure Panel Survey 2009-2018. JACC Heart Fail. 2022 Aug;10(8):571-580. doi: 10.1016/j.jchf.2022.05.006. Epub 2022 Jul 6.
PubMed 35902161Akintoye E, Briasoulis A, Egbe A, Adegbala O, Sheikh M, Singh M, Alliu S, Ahmed A, Asleh R, Kushwaha S, Levine D. Regional Variation in Mortality, Length of Stay, Cost, and Discharge Disposition Among Patients Admitted for Heart Failure in the United States. Am J Cardiol. 2017 Sep 1;120(5):817-824. doi: 10.1016/j.amjcard.2017.05.058. Epub 2017 Jun 15.
PubMed 28705376Khan H, Greene SJ, Fonarow GC, Kalogeropoulos AP, Ambrosy AP, Maggioni AP, Zannad F, Konstam MA, Swedberg K, Yancy CW, Gheorghiade M, Butler J; EVEREST Trial Investigators. Length of hospital stay and 30-day readmission following heart failure hospitalization: insights from the EVEREST trial. Eur J Heart Fail. 2015 Oct;17(10):1022-31. doi: 10.1002/ejhf.282. Epub 2015 May 9.
PubMed 25960401Sud M, Yu B, Wijeysundera HC, Austin PC, Ko DT, Braga J, Cram P, Spertus JA, Domanski M, Lee DS. Associations Between Short or Long Length of Stay and 30-Day Readmission and Mortality in Hospitalized Patients With Heart Failure. JACC Heart Fail. 2017 Aug;5(8):578-588. doi: 10.1016/j.jchf.2017.03.012. Epub 2017 May 10.
PubMed 28501521Reeves GR, Whellan DJ, Patel MJ, O'Connor CM, Duncan P, Eggebeen JD, Morgan TM, Hewston LA, Pastva AM, Kitzman DW. Comparison of Frequency of Frailty and Severely Impaired Physical Function in Patients >/=60 Years Hospitalized With Acute Decompensated Heart Failure Versus Chronic Stable Heart Failure With Reduced and Preserved Left Ventricular Ejection Fraction. Am J Cardiol. 2016 Jun 15;117(12):1953-8. doi: 10.1016/j.amjcard.2016.03.046. Epub 2016 Apr 6.
PubMed 27156830Sica DA, Muntendam P, Myers RL, Ter Maaten JM, Sale ME, de Boer RA, Pitt B. Subcutaneous Furosemide in Heart Failure: Pharmacokinetic Characteristics of a Newly Buffered Solution. JACC Basic Transl Sci. 2018 Feb 7;3(1):25-34. doi: 10.1016/j.jacbts.2017.10.001. eCollection 2018 Feb.
PubMed 30062191
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure: A Cluster-Randomized Crossover Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07018297
- Acronym / sponsor ID
- STU2025-0766
- Conditions
- Heart Failure, Acute Decompensated Heart Failure
- Keywords
- Subcutaneous Furosemide, Length of Stay (LOS), Hospitalization, Resource Allocation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Aug 2028 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HF contributes to over 1 million emergency department visits and nearly 1 million hospitalizations annually. The estimated annual mean cost per person with HF was $32,955 in 2017-2018, with the majority of costs due to hospitalization. The current standard of care typically involves admission for intravenous (IV) diuretics, monitoring for adequate decongestion, transition to oral diuretics, and discharge once clinical stability is achieved. The median length of stay for HF hospitalizations in the United States is 5 days but varies significantly across health systems and at the patient level. Extended hospitalizations, while traditionally considered necessary for complete decongestion, carry substantial risks, including increased risk of all-cause death and readmission. Patients experience deconditioning and increased frailty and are at risk for hospital-acquired complications, including infections, falls, and cognitive decline. Furthermore, prolonged hospitalization can lead to post-hospital syndrome, characterized by increased vulnerability and risk for adverse events in the immediate post-discharge period. For these reasons, reducing length of stay has emerged as a critical goal in HF management, aimed at both decreasing costs and improving patient outcomes by minimizing hospital-related complications and preserving quality of life.
Recent developments in subcutaneous furosemide formulations offer a potential solution to this clinical challenge. Pharmacokinetic studies demonstrate that subcutaneous furosemide achieves bioavailability comparable to IV administration and superior to oral formulations. The consistent absorption profile and reliable bioavailability of subcutaneous furosemide, combined with its ease of administration, presents an opportunity to provide hospital-level diuresis in the outpatient setting. This could enable earlier discharge while maintaining the intensity of diuretic therapy needed for complete decongestion. However, a critical knowledge gap exists regarding the safety and efficacy of an early discharge strategy utilizing subcutaneous furosemide compared to traditional inpatient management.
This trial aims to address this knowledge gap through a cluster-randomized crossover study comparing early discharge with subcutaneous furosemide to standard inpatient care and receipt of IV furosemide. By implementing standardized protocols across two major health systems, the investigators will evaluate whether this novel approach can safely reduce length of stay while maintaining clinical outcomes. The study design accounts for institutional variations in care delivery while providing robust data on safety, efficacy, and resource utilization. Results from this trial could fundamentally change the management paradigm for acute heart failure hospitalizations, potentially improving both healthcare efficiency and patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization at the cluster level (hospitalist subgroups, academic teaching teams, and cardiology practice groups). Each participating cluster will implement either the early discharge strategy or standard care for initial two-month blocks, followed by a crossover to the alternate strategy.
| Arm | Type | Receives |
|---|---|---|
| Early Discharge with Subcutaneous Furosemide | Experimental | Combination Product: Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-InfusorThe practice group randomized to early discharge with subcutaneous furosemide home infusion will begin initiation of subcutaneous furosemide (LASIX-ONYU) with a SQIN-Infusor device prior to discharge from the hospital. Dosing will be based on pre-admission oral furosemide requirements. Those with a home dose of ≤80mg/day oral furosemide will receive 80mg subcutaneous once daily at home and those with >80mg/day oral furosemide will receive 80mg subcutaneous twice daily at home. |
| Usual Care | No intervention | –Usual inpatient care with IV furosemide. Discharge timing determined by treating physician per standard practice. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Cognitive impairment preventing informed consent
- Geographic barriers to follow-up
- Pregnancy or breastfeeding
- IV furosemide requirement >250mg/day
- eGFR <20 mL/min/1.73m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-InfusorAlso: subcutaneous furosemideEach practice group randomized to early discharge with subcutaneous furosemide will provide the patient with prefilled units of Lasix® ONYU furosemide injection containing 80 mg per 2.67 mL in a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor that will be used in conjunction with the reusable unit of the Lasix ONYU Infusor. Dosing based on pre-admission oral furosemide requirements: ≤80mg/day oral furosemide will be given 80mg subcutaneous once daily or >80mg/day oral furosemide will be given 80mg subcutaneous twice daily. Dosing will be continued until clinical euvolemia is reached. | Combination product | Early Discharge with Subcutaneous Furosemide |
Primary outcome
Days alive and out of the hospital
Time frame: 30-day
Days alive and out of the hospital will be ascertained via retrospective review of the electronic health record.
3 secondary outcomes
Change in Quality of Life
Time frame: Baseline, 14-day, and 30-day. The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where 0 is worst quality of life and 100 is best quality of life.
Change in N-terminal pro B-type natriuretic peptide
Time frame: Baseline, 14-day, and 30-day
Time-to-event for mortality and readmission
Time frame: 30-day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 37797885Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. No abstract available.
- Background: PubMed 35902161Bhatnagar R, Fonarow GC, Heidenreich PA, Ziaeian B. Expenditure on Heart Failure in the United States: The Medical Expenditure Panel Survey 2009-2018. JACC Heart Fail. 2022 Aug;10(8):571-580. doi: 10.1016/j.jchf.2022.05.006. Epub 2022 Jul 6.
- Background: PubMed 28705376Akintoye E, Briasoulis A, Egbe A, Adegbala O, Sheikh M, Singh M, Alliu S, Ahmed A, Asleh R, Kushwaha S, Levine D. Regional Variation in Mortality, Length of Stay, Cost, and Discharge Disposition Among Patients Admitted for Heart Failure in the United States. Am J Cardiol. 2017 Sep 1;120(5):817-824. doi: 10.1016/j.amjcard.2017.05.058. Epub 2017 Jun 15.
- Background: PubMed 25960401Khan H, Greene SJ, Fonarow GC, Kalogeropoulos AP, Ambrosy AP, Maggioni AP, Zannad F, Konstam MA, Swedberg K, Yancy CW, Gheorghiade M, Butler J; EVEREST Trial Investigators. Length of hospital stay and 30-day readmission following heart failure hospitalization: insights from the EVEREST trial. Eur J Heart Fail. 2015 Oct;17(10):1022-31. doi: 10.1002/ejhf.282. Epub 2015 May 9.
- Background: PubMed 28501521Sud M, Yu B, Wijeysundera HC, Austin PC, Ko DT, Braga J, Cram P, Spertus JA, Domanski M, Lee DS. Associations Between Short or Long Length of Stay and 30-Day Readmission and Mortality in Hospitalized Patients With Heart Failure. JACC Heart Fail. 2017 Aug;5(8):578-588. doi: 10.1016/j.jchf.2017.03.012. Epub 2017 May 10.
- Background: PubMed 27156830Reeves GR, Whellan DJ, Patel MJ, O'Connor CM, Duncan P, Eggebeen JD, Morgan TM, Hewston LA, Pastva AM, Kitzman DW. Comparison of Frequency of Frailty and Severely Impaired Physical Function in Patients >/=60 Years Hospitalized With Acute Decompensated Heart Failure Versus Chronic Stable Heart Failure With Reduced and Preserved Left Ventricular Ejection Fraction. Am J Cardiol. 2016 Jun 15;117(12):1953-8. doi: 10.1016/j.amjcard.2016.03.046. Epub 2016 Apr 6.
- Background: PubMed 30062191Sica DA, Muntendam P, Myers RL, Ter Maaten JM, Sale ME, de Boer RA, Pitt B. Subcutaneous Furosemide in Heart Failure: Pharmacokinetic Characteristics of a Newly Buffered Solution. JACC Basic Transl Sci. 2018 Feb 7;3(1):25-34. doi: 10.1016/j.jacbts.2017.10.001. eCollection 2018 Feb.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor in people with Heart Failure and Acute Decompensated Heart Failure, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ambarish Pandey, MD (214-645-2101, ambarish.pandey@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive and out of the hospital (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07018297, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.