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Chloride pills tested for heart failure fluid control

NCT ID NCT03440970

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase study tested whether giving chloride supplements (lysine chloride) to people with stable heart failure could affect their body's fluid balance. Twenty participants took either the supplement or a placebo three times daily for five days. The goal was to understand how chloride affects blood volume and kidney function, not to treat symptoms directly.

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 successful, this could point toward a new way to manage fluid balance in heart failure patients.
What could go wrong
This is a very small, early-phase study with only 20 participants. It is designed to gather basic information, not to prove a treatment works.

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

20 people

The number who actually took part.

Started

Jan 2019

Finished

Aug 2025

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: * Meticulous history of medical compliance and attendance of appointments * Stable heart failure as defined by: 1. Absence of hospitalizations for 90 days 2. Stable diuretic and medical therapy for 30 days 3. Opinion of the patient's treating physician (Heart Failure Cardiologist) that the patient is at optimal volume status * Evidence based heart failure treatment with maximally-tolerated doses of a beta blocker, ACE/ARB/neprilysin inhibitor and aldosterone antagonist * Chronic loop diuretic therapy with ≥ 40 mg of furosemide equivalents * Serum chloride \<102 mmol/L Exclusion Criteria: * Inability to commit to or comply with the rigorous study protocol * Use of a thiazide diuretic in the last 30 days * History of metabolic or respiratory acidosis * 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 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 * Serum pH \<7.3 * Estimated glomerular filtration rate \<30 mL/min or prior or current history of renal replacement therapy * Anemia, as defined by Hemoglobin \<8.0 g/dL at screening visit * Urinary incontinence or significant bladder dysfunction (post-void residual at screening \>300 mL) * Use of chloride containing medications that provide more than 5 mmol/day of chloride if the medication cannot be discontinued or substituted * Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research 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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Yale University

    New Haven, Connecticut, 06510, United States

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