Lysine Chloride for Heart Failure

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Yale University

Must be taking: Beta blockers, ACE/ARB, Aldosterone antagonists, Loop diuretics

Must not be taking: Thiazide diuretics, Metformin

Disqualifiers: Acidosis, Renal failure, Anemia, others

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is designed to investigate the quantitative effects of sodium-free chloride supplementation on electrolyte balance, volume status, and sodium avidity in stable heart failure patients in a highly controlled environment.

Will I have to stop taking my current medications?

The trial requires that you stay on your current heart failure medications, but you may need to stop taking metformin during certain parts of the study. If you are using a thiazide diuretic or certain chloride-containing medications, you may need to stop those as well.

How is the drug Lysine Chloride unique for treating heart failure?

Lysine Chloride is unique because it is primarily known as a supplement for conditions like herpes simplex infections and has potential applications in cardiovascular disease, making its use in heart failure novel compared to standard treatments. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

My heart failure is stable, with no hospital visits in 3 months, and I'm on a strict medication regimen.

Meticulous history of medical compliance and attendance of appointments

Exclusion Criteria

I have taken a water pill in the last month.

My hemoglobin level is below 8.0 g/dL.

I am not taking medications like metformin that could cause acidosis, or I can stop metformin safely for the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive lysine chloride or placebo twice a day for 5 days after a blood volume assessment

5 days

Daily visits (inpatient)

Follow-up

Participants are monitored for changes in blood volume, NTpro-BNP, chloride, serum creatinine, cystatin C, and bicarbonate

7 days

Daily monitoring (inpatient)

Treatment Details

Interventions

• Lysine Chloride (Electrolyte Supplement)
• Placebo (Other)

Trial Overview 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.

Participant Groups

Group I: Lysine Chloride Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Lysine Chloride is already approved in Japan, India for the following indications:

Approved in Japan as Lysine Hydrochloride for:

• Herpes simplex prophylaxis and treatment
• Anxiety

Approved in India as Lysine Hydrochloride for:

• Herpes simplex prophylaxis and treatment
• Lysinuric protein intolerance
• Nephroprotection
• Schizophrenia
• Muscle recovery

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a feed additive consisting of l-lysine monohydrochloride and l-lysine sulfate produced by fermentation with Corynebacterium glutamicumCGMCC 17927 for all animal species (Barentz Animal Nutrition B.V.). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a feed additive consisting of l-lysine monohydrochloride and l-lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 for all animal species (Kempex Holland BV). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The metabolic roles, pharmacology, and toxicology of lysine. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of l-lysine monohydrochloride and l-lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 for all animal species. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of concentrated liquid l-lysine (base) and l-lysine monohydrochloride produced by fermentation with Corynebacterium casei KCCM 80190 as feed additives for all animal species. [2023]