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Electrolyte Supplement

Lysine Chloride for Heart Failure

Phase < 1

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Anemia, as defined by Hemoglobin <8.0 g/dL at screening visit

Urinary incontinence or significant bladder dysfunction (post-void residual at screening >100 mL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily for 7-days

Summary

This trial will study the effects of a salt-free diet on heart failure patients.

Who is the study for?

This trial is for stable heart failure patients with an ejection fraction below 40%, on chronic loop diuretic therapy, and a serum chloride level under 102 mmol/L. They must have no hospitalizations in the past 90 days, be on evidence-based treatments, and have a history of following medical advice. Exclusions include those unable to follow the study protocol, using certain medications like metformin or thiazide diuretics recently, with severe kidney issues or significant blood sugar problems.

What is being tested?

The trial is testing how sodium-free chloride supplementation (Lysine Chloride) affects electrolyte balance and fluid status compared to a placebo in heart failure patients. The goal is to understand if manipulating chloride levels can improve heart function by studying changes in volume status and sodium retention.

What are the potential side effects?

Potential side effects are not explicitly listed but may include imbalances in electrolytes leading to muscle cramps or weakness, digestive disturbances such as nausea or diarrhea from lysine chloride supplementation, and possible interactions with other medications.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My hemoglobin level is below 8.0 g/dL.

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I have issues controlling my bladder or emptying it completely.

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I am taking a medication with more than 5 mmol/day of chloride that cannot be stopped.

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My kidney function is very low or I am on dialysis.

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I have had metabolic or respiratory acidosis in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily for 7-days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily for 7-days

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily for 7-days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Blood Volume

Secondary study objectives

Change in Bicarbonate

Chlorides

Change in Cystatin C

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lysine ChlorideExperimental Treatment1 Intervention

Patients will be randomized to receive either lysine chloride or placebo. Patients will receive the study drug twice a day for 5 days of randomized therapy, starting after the completion of a blood volume assessment.

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lysine Chloride

2018

Completed Early Phase 1

~70

0 / 5Eligibility criteria met