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Study of Bumetanide Dosing in Heart Failure

This study is looking into how different doses of a medicine called bumetanide affect people with heart failure. Bumetanide is a diuretic, which helps your body get rid of extra fluid. We want to understand why some people with heart failure don't respond well to diuretics. You would receive different doses of bumetanide (1.25mg, 2.5mg, 5mg, or 10mg) in a random order over several visits. To join, you need to have a heart failure diagnosis, be at least 18 years old, and not have severe kidney problems. The study aims to see how your body's kidney function changes after receiving bumetanide. The current status of this study is unclear, and it plans to enroll 75 participants.

Study design
This study is designed as a randomized, double-blind study, meaning neither you nor the study team will know which dose you are receiving at each visit. It involves 75 participants with heart failure.
What's involved
You would have a screening visit, then follow a special diet for five days before your first treatment day. You would then visit the study site every 3 days to receive different doses of bumetanide, with two full days in between visits.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements are taken at baseline and 1 hour after bumetanide infusion during each visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05323487

Mechanisms of Diuretic Resistance in Heart Failure, Aim 1

Recruiting
PHASE1Ages 18+Interventional
Yale University
~75 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Bumetanide Injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in fractional excretion of lithium(FELi) pre-diuretic to 1-hour post IV bumetanide infusion
Measured over Baseline and 1 hour post bumetanide infusion.
+3 more outcomes measured

Conditions

Heart Failure

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Heart Failure

NCT05323487

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Yale University

    New Haven, Connecticutstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeffrey Testani · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Veena Rao
[email protected]
2037373571
Email the study team

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Eligibility criteria

Inclusion

Clinical diagnosis of HF
No plan for titration/change of heart failure medical or device therapies during the study period.
Absence of non-elective hospitalizations in the previous 3 months.
At optimal volume status by symptoms, exam, and dry weight
Age \> 18 years

Exclusion

GFR \<20 ml/min/1.73m2 using the Chronic Kidney Disease- Epidemiology (CKD-EPI)equation or use of renal replacement therapies
Use of any non-loop type diuretic in the last 14 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone or eplerenone ≤50 mg). Examples of non-loop diuretics include but may not be limited to acetazolamide (oral or IV, not ophthalmic), metolazone, Hydrochlorothiazide (HCTZ), chlorthalidone, chlorothiazide, indapamide, triamterene, amiloride, finerenone, spironolactone dose \> 50mg day, eplerenone \> 50mg/day,
History of flash pulmonary edema requiring hospitalization and treatment with biphasic positive airway pressure or mechanical ventilation or a "brittle" volume sensitive HF phenotype such as an infiltrative or restrictive cardiomyopathy (i.e. amyloid cardiomyopathy, etc).
Hemoglobin \< 8 g/dL
Pregnant or breastfeeding
Inability to give written informed consent or comply with study protocol or follow-up visits
Chronic Urinary retention limiting ability to perform timed urine collection procedures

What this trial measures

  • Change in fractional excretion of lithium(FELi) pre-diuretic to 1-hour post IV bumetanide infusionBaseline and 1 hour post bumetanide infusion.

    The fractional excretion of lithium is used for interrogation of sodium handling in the proximal tubule and loop of Henle. Possible values range from 0 to 100%. Change = FELi 1 hour post bumetanide infusion - FELi pre-diuretic. Different doses of bumetanide will be given at days 0, 3, 6 and 9.

  • Change in distal sodium reabsorption pre-diuretic to 1-hour post IV bumetanide infusionBaseline and 1 hour post bumetanide infusion.

    The distal sodium reabsorption is used to for interrogation of how much sodium is being reabsorbed in the distal tubule. Possible values range from 0 to 100%. Distal sodium reabsorption is calculated = Fractional excretion of lithium - fractional excretion of sodium. Change in distal sodium reabsorption = distal sodium reabsorption 1 hour post bumetanide infusion - distal sodium reabsorption pre-diuretic. Different doses of bumetanide will be given at days 0, 3, 6 and 9.

  • Tubular diuretic efficiency at baselineBaseline

    The tubular diuretic efficiency is used to assess the response to loop diuretics based on the amount of sodium excreted but eliminates drug delivery as source of diuretic resistance. Possible values range from 0 to 100%. Greater numbers imply better diuretic efficiency. Tubular diuretic efficiency will be compared between diuretic resistant and diuretic responsive patients using the 6 hour urine collection after bumetanide infusion.

  • Ratio of A to F splice variant Messenger Ribonucleic Acid (mRNA )in urinary extracellular vesicles at baselineBaseline

    The ratio of A to F splice variant mRNA in urinary extracellular vesicles refers to the splice variants in the NKCC2 channel. The F variant has low-chloride-affinity-high-capacity, and the A variant has high-chloride-affinity-high-capacity. Possible values are greater than zero. The ratio of A to F splice variant will be compared between diuretic resistant and diuretic responsive patients. The ratio will be compared using the baseline urine sample.