20 Participants Needed

Lysine Chloride for Heart Failure

KK
JM
Overseen ByJeffrey M Testani
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Yale University
Must be taking: Beta blockers, ACE/ARB, Aldosterone antagonists, Loop diuretics
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

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.
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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
  • Placebo
Trial OverviewThe 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
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
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 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

Find a Clinic Near You

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+

Findings from Research

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

References

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]
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]
The metabolic roles, pharmacology, and toxicology of lysine. [2019]
Safety and efficacy of l-lysine monohydrochloride and l-lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 for all animal species. [2020]
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]