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Could a simple salt supplement boost fluid removal in heart failure?

NCT ID NCT03446651

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether adding a chloride supplement (lysine chloride) to standard IV diuretics helps people with acute heart failure get rid of excess fluid more effectively. Participants take the supplement or a placebo for 7 days while receiving usual care. The study measures changes in blood volume and a heart failure biomarker to see if chloride supplementation improves fluid balance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lysine chloride
What this could lead to
If effective, this could lead to a simple oral supplement that helps heart failure patients clear excess fluid faster and more safely.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not be conclusive. The supplement may cause taste issues or other side effects.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

50 people

The number who actually took part.

Started

Jul 2018

Finished

Sep 2022

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 decompensated heart failure with at least one objective sign of volume overload (rales, edema, elevated jugular venous pressure (JVP), or weight gain of at least 5 pounds) * A projected need by the treating clinician for continued treatment with IV diuretics * Chronic loop diuretic use Exclusion Criteria: * Inability to commit to or comply with serial visits for treatment in the Yale Transitional Care Center (YTCC) * History of severe metabolic or respiratory acidosis within 30 days of enrollment * 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 discontinued safely for the duration of the study. Any participants who have consistently elevated Blood glucose readings \> 200 mg/dL while inpatient will not be enrolled. * Serum bicarbonate level \<20mmol/L * Estimated glomerular filtration rate \<20 mL/min or renal replacement therapy * Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research registered nurse (RN) (ex: clinically-significant psychiatric, addictive, or neurological disease) * Inability to give written informed consent or follow study protocol

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Yale University

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.