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Yale study investigates diuretic resistance in heart failure

NCT ID NCT06209359

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

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