Chloride pills tested for heart failure fluid control
NCT ID NCT03440970
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.
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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
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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.
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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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Other studies related to the condition(s) this trial covers.
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