Could a simple shot replace the IV for heart failure fluid removal?
NCT ID NCT06167707
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new version of the water pill furosemide that can be injected under the skin (subcutaneous) using an autoinjector, comparing it to the standard IV form given in a hospital. The study involved 21 healthy volunteers aged 45 to 80 to see how the drug is absorbed and how much urine it produces. The goal is to see if this easier method could one day help heart failure patients manage fluid buildup at home.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Furosemide (a water pill)
- What this could lead to
- If successful, this could lead to a convenient way for heart failure patients to receive furosemide at home via a simple injection under the skin, instead of needing an IV in a hospital.
- What could go wrong
- This is a very early Phase 1 study in only 21 healthy people, not heart failure patients. It is designed to measure drug levels and safety, not to prove it works for treating fluid overload. The results may not apply to actual patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
21 people
The number who actually took part.
- Started
-
Apr 2024
- Finished
-
Jun 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 2. Male and female subjects 45 to 80 years of age. 3. Has the ability to understand the requirements of the study and is willing to comply with all study procedures. 4. In the opinion of the Investigator, able to participate in the study. Exclusion Criteria: 1. Pregnant or lactating women or women of childbearing age who are not willing to use an adequate form of contraception. 2. Systolic BP (SBP) \< 90 mmHg at screening or baseline. 3. Heart rate \> 110 beats per minute (BPM) at screening or baseline. 4. Temperature \> 38°C (oral or equivalent). 5. Serum potassium \< 3.0 or \> 5.5 mEq/L at screening. 6. Other significant cardiac abnormalities which may interfere with study participation or study assessments. 7. Current or planned treatment during the study with any IV therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues. scPharmaceuticals, Inc. SCP-111 PK/PD Study Protocol Number: scP-04-001 Confidential Page 14 of 56 8. Presence of implanted ventricular assist device, cardiac defibrillator or pacemaker. 9. Severely impaired renal function, defined as an estimated glomerular filtration rate (eGFR) at screening admission \< 30 mL/min/1.73m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation. 10. Urinary retention due to bladder emptying disorders and/or urethral narrowing. 11. Presence or need for urinary catheterization. 12. Reported history of hepatic cirrhosis. 13. Administration of intravenous radiographic contrast agent within 72 hours prior to Screening. 14. Concomitant or any use within past 30 days of drugs known to interact with furosemide (aminoglycoside antibiotics, ethacrynic acid, high doses of salicylates, cisplatin, tubocurarine, succinylcholine, chloral hydrate, phenytoin, methotrexate, indomethacin, or lithium). 15. Administration of an investigational drug or implantation of investigational device, or participation in another interventional clinical trial, within 30 days prior to Screening. 16. Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study. 17. Positive urine drug screen at Screening or Baseline. 18. Blood alcohol concentration \> 2 mg/dL (0.02%) at Screening. 19. Alcohol breath test \> 2 mg/dL (0.02%) on admission to the CRU. 20. History of severe allergic or hypersensitivity reactions to furosemide or any component of the SCP-111 formulation (tromethamine or benzyl alcohol)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Elixia EPCT, LLC
Tampa, Florida, 33618, United States
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