Lysine Chloride for Heart Failure

Recruiting in New Haven (>99 mi)

Overseen By Jeffrey M Testani

Age: 18+

Sex: Any

Trial Phase: Phase < 1

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 This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

20 Participants Needed

What You Need to Know Before You Apply

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}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Lysine Chloride
• Placebo

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.

How Is the Trial Designed?

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 thrice daily 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 thrice daily for 5 days of randomized therapy, starting after the completion of a blood volume assessment.

Lysine Chloride is already approved in United States, European Union, Japan, India for the following indications:

Approved in United States as Lysine Hydrochloride for:

• Herpes simplex prophylaxis and treatment
• Lysinuric protein intolerance
• Nephroprotection

Approved in European Union as Lysine Hydrochloride for:

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

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+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The use of l-lysine monohydrochloride and l-lysine sulfate produced by the genetically modified strain C. glutamicum CGMCC 17927 is safe for all animal species and does not pose safety concerns regarding the production strain, as no viable cells or recombinant DNA were found in the final products.

Both forms of l-lysine are effective nutritional additives for non-ruminant animals, but for ruminants, additional protection against degradation in the rumen is necessary to ensure efficacy.

NCBI (Pubmed)

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.). Bampidis, V., Azimonti, G., de Lourdes Bastos, M., et al.[2022]

L-lysine monohydrochloride and l-lysine sulfate produced by Corynebacterium glutamicum CGMCC 14498 are considered safe for all animal species and do not pose safety concerns for consumers or the environment.

These forms of l-lysine are effective nutritional feed additives for non-ruminant animals, but additional protection would be needed for their efficacy in ruminants due to potential degradation in the rumen.

NCBI (Pubmed)

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). Bampidis, V., Azimonti, G., Bastos, ML., et al.[2022]

L-lysine monohydrochloride (LMH) is primarily used as a nonprescription supplement to help suppress recurrent herpes simplex infections, indicating its efficacy in managing this viral condition.

Recent studies suggest that LMH may have potential therapeutic uses beyond herpes, including applications in cardiovascular disease and osteoporosis, warranting further research into its broader health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

l-Lysine monohydrochloride and l-lysine sulfate produced by Corynebacterium glutamicum CGMCC 7.266 are considered safe for animals, consumers, and the environment, with no safety concerns related to the genetic modification of the production strain.

Both forms of l-lysine are effective nutritional additives for all animal species, but they need protection against degradation in the rumen to be as effective in ruminants as they are in non-ruminants.

NCBI (Pubmed)

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. Bampidis, V., Azimonti, G., Bastos, ML., et al.[2020]

Concentrated liquid l-lysine and l-lysine HCl produced from the genetically modified strain Corynebacterium casei KCCM 80190 are safe for use in animal feed, as they do not pose risks to animals, consumers, or the environment, and no harmful genetic modifications were detected in the final products.

While both forms of l-lysine are effective for non-ruminant animals, additional protection would be needed for ruminants to ensure the l-lysine remains effective in their digestive systems.

NCBI (Pubmed)

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. Bampidis, V., Azimonti, G., Bastos, ML., et al.[2023]

Citations

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]