Heart failure drug shot could replace IV needles
NCT ID NCT04384653
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new way to give the heart failure drug furosemide: as a shot under the skin instead of through an IV. Twenty adults with chronic heart failure received both versions to compare how much drug gets into the body. The goal is to see if the shot works well enough to offer a simpler, more convenient option for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- furosemide
- What this could lead to
- If successful, this could offer a more convenient way to give furosemide to heart failure patients, potentially allowing treatment at home instead of in a hospital.
- What could go wrong
- This is an early-stage study with only 20 people, so results may not apply to everyone. The new shot is not expected to work exactly like the IV version, and it may not be as effective or could cause skin reactions.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
20 people
The number who actually took part.
- Started
-
Oct 2020
- Finished
-
Jun 2021
- 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
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * An Institutional Review Board (IRB)-approved informed consent is signed and dated prior to any study-related activities. * Male and female subjects ≥18 and ≤ 80 years of age, with body weight \<130 kg and body mass index (BMI) \<38 kg/m2. * Females will be non-pregnant, non-lactating, or post-menopausal, or surgically sterile (e.g., tubal ligation, hysterectomy), * Females of childbearing potential will use TWO of the following forms of contraception: intrauterine device (IUD), IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, a sterile sexual partner. * History of at least 3 months treated heart failure (NYHA class II/III) with presence of symptoms of chronic volume overload requiring ongoing treatment with oral furosemide at a dose of ≥40 mg per day for at least 30 days prior to Day -1. * Agrees to abstain from using alcohol, caffeine-containing products, and tobacco-/nicotine-containing products while in residence at the CRU. * Able to participate in the study in the opinion of the Investigator. * Has the ability to understand the requirements of the study and is willing to comply with all study procedures. Exclusion Criteria: * Acute Decompensated Heart Failure (ADHF) or recent history of hospitalization for heart failure in the last 4 weeks. * Worsening of signs or symptoms of heart failure in the two weeks prior to the Screening, or those expected to require IV loop diuretics or inpatient treatment for heart failure during the study. * Systolic blood pressure (SBP) \<90 mmHg. * Temperature ≥38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment. * Serum sodium \<130 mEq/L and serum potassium \<3.5 mEq/L. * Significant other cardiac abnormalities which may interfere with study participation or study assessments. * Current or planned treatment during the study with any IV therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues; or mechanical support (intraaortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device). * Subject is cachectic. * Diagnosed with Type I diabetes mellitus or Type II diabetes requiring insulin therapy. * Presence or need for urinary catheterization, urinary tract abnormality, or disorder interfering with urination. * Impaired renal function, defined as an estimated glomerular filtration rate (eGFR) on admission \<45 mL/min/1.73m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation. * Indication of moderate-to-severe hepatic dysfunctions as determined by the Investigator. * Administration of IV radiographic contrast agent within 72 hours prior to Screening or acute contrast-induced nephropathy at the time of Screening. * Major surgery within 30 days prior to Screening. * Administration of an investigational drug or implantation of investigational device, or participation in another interventional trial, within 30 days prior to Screening. * Any surgical or medical condition, which in the opinion of the Investigator may pose an undue risk to the subject, interfere with participation in the study, or which may affect the integrity of the study data. * Positive test for hepatitis B (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) at Screening. * Any positive urine drug screen at Screening or clinic admission. * Concomitant use of any drugs known to interact with furosemide. * History of alcohol abuse within 6 months prior to Screening and/or signs or symptoms of alcoholism, as determined by the Investigator. * Any positive alcohol test on admission to the CRU. * History of severe allergic or hypersensitivity reactions to furosemide. * Donation of greater than 100 mL of either whole blood or plasma within 30 days prior to study drug administration. * Been informed of possible COVID-19 exposure in past 4 weeks, or recent onset of signs or symptoms of possible COVID-19 infection, including cough, shortness of breath, or temperature ≥ 38°C . * Traveled via airplane or cruiseship within the last 14 days.
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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
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Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720, United States
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