Yale study investigates diuretic resistance in heart failure
NCT ID NCT06209359
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looks at why some people with heart failure don't respond well to diuretics (water pills). Researchers will give 50 participants either ammonium chloride or a placebo, along with standard diuretics, to see how it affects kidney function. The goal is to understand the body's sodium handling better, which could improve future treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ammonium chloride
- What this could lead to
- If successful, this could help doctors understand why some heart failure patients are resistant to diuretics, potentially leading to better treatment strategies.
- What could go wrong
- This is a small, early-phase study (50 participants) focused on understanding mechanisms, not on proving a new treatment works. Results may not apply to all heart failure 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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Clinical diagnosis of heart failure * No plan for titration/change of heart failure medical or device therapies during the study period. * Absence of non-elective hospitalizations in the previous 2 months. * At optimal volume status by symptoms, exam, and dry weight. * Serum potassium ≤ 5.0 mmol/L * Serum sodium ≥ 130 milliequivalents/ liter (mEq/L) * Hemoglobin ≥8 g/dL * Age \>18 years * Objective evidence of diuretic resistance to a 10mg bumetanide challenge (screening visit may occur under this protocol or HIC2000032328 or HIC2000034315) defined as: * FENa \<10% and total sodium output \<150mmol * And at least one of the following criteria: * Chronic home furosemide dose greater than or equal to 80mg furosemide equivalents * eGFR \< 60ml/min * Serum chloride \<100mmol/L * FENa \<5% and total sodium output \<75mmol on the 2 hour Exclusion Criteria: * Glomerular filtration rate (GFR) \<20 ml/min/1.73m2 * Use of any non-loop type diuretic in the last 7 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone ≤50 mg) * History of flash pulmonary edema or a "brittle" volume sensitive HF phenotype such as amyloid cardiomyopathy * Hemoglobin \< 8 g/dL * Pregnant or breastfeeding * Cirrhosis or known liver disease * History of metabolic or respiratory acidosis within 30 days * Use of metformin, acetazolamide, or any other agent that could predispose to acidosis * Patients who are on metformin may be enrolled if their metformin can be safely discontinued for the randomized treatment periods in each arm. Any participants who have consistently elevated blood glucose readings \> 200 mg/dL while inpatient will not be enrolled. * Serum bicarbonate level \<24mmol/L at screening visit * Venous potential of hydrogen(pH) \<7.35 at screening visit * Inability to give written informed consent or comply with study protocol or follow-up visits * On Lithium therapy * On pimozide or thioridazine * Diagnosis of liver failure * Contraindications or allergy to sulfonamides * Any contraindication to thiazide diuretic or allergy to thiazide or bendroflumethiazide
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yale University
RECRUITINGNew Haven, Connecticut, 06510, United States
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