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?
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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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 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
Research Locations NearbySelect from list below to view details:
Yale UniversityNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
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]Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-lysine monohydrochloride and l-lysine sulfate produced by Corynebacterium glutamicum CGMCC 17927, when used as a nutritional additive in feed and water for drinking for all animal species. The active substance is l-lysine, and it was produced in two different forms: monohydrochloride (HCl) or sulfate salts. The production strain was genetically modified. Neither viable cells nor recombinant DNA of the production strain were detected in the final products. Therefore, the Panel concluded that the additives did not pose any safety concern regarding the production strain. The use of l-lysine HCl and l-lysine sulfate produced by the strain C. glutamicum CGMCC 17927 in supplementing feed to compensate for l-lysine deficiency in feedingstuffs was safe for the target species. The FEEDAP Panel identified risks of nutritional imbalances and hygienic concerns for amino acids when administered simultaneously in feed and in water for drinking. The use of both forms of l-lysine produced by fermentation using C. glutamicum CGMCC 17927 in animal nutrition was considered safe for the consumers and for the environment. Exposure of users through inhalation to l-lysine HCl and l-lysine sulfate produced with C. glutamicum CGMCC 17927 was considered very likely. In absence of data, the FEEDAP Panel could not conclude on the potential of both forms of the additive to be irritant for skin and eyes or to be dermal sensitisers. l-Lysine HCl and l-lysine sulfate were considered as efficacious sources of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against 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). [2022]Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-lysine monohydrochloride (l-lysine HCl) and l-lysine sulfate produced by Corynebacterium glutamicum (C. glutamicum) CGMCC 14498 as a nutritional feed additive for all animal species. The active substance is l-lysine and it is produced in two different forms (monohydrochloride or sulfate). The production strain C. glutamicum CGMCC 14498 and its recombinant DNA were not detected in the final products. The products l-lysine HCl and l-lysine sulfate do not pose any safety concern associated with the production strain. l-Lysine HCl and l-lysine sulfate produced by C. glutamicum CGMCC 14498 are considered safe for the target species. When using l-lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l-Lysine HCl and l-lysine sulfate produced by C. glutamicum CGMCC 14498 are safe for the consumer and the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l-lysine HCl produced by the strain C. glutamicum CGMCC 14498 to be toxic by inhalation, and on the potential of l-lysine HCl and l-lysine sulfate produced by the above-mentioned strain to be irritant to skin or eyes, or on their potential to be dermal sensitisers. l-Lysine HCl and l-lysine sulfate produced by C. glutamicum CGMCC 14498 are considered efficacious sources of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, this would require protection against degradation in the rumen.
The metabolic roles, pharmacology, and toxicology of lysine. [2019]L-lysine monohydrochloride (LMH) is widely available to the public as a nonprescription oral supplement. Most of the pharmaceutical-grade product is used as a suppressant of recurrent herpes simplex infections. Recent publications indicate the possibility of other therapeutic uses, e.g., in cardiovascular disease and osteoporosis. These and other potential applications are surveyed and evaluated in this review with suggestions for further study. Data on toxicity are reviewed and recommendations made regarding safety of chronic dosage levels.
Safety and efficacy of l-lysine monohydrochloride and l-lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 for all animal species. [2020]Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-lysine monohydrochloride and l-lysine sulfate produced using Corynebacterium glutamicum CGMCC 7.266 when used as a nutritional additive in feed and water for drinking for all animal species. The active substance is l-lysine and it is produced in two different forms (monohydrochloride or sulfate salts). None of those forms pose any safety concern associated with the genetic modification of the production strain. l-Lysine HCl and l-lysine sulfate produced by C. glutamicum CGMCC 7.266 are considered safe for the target species, for the consumer and for the environment. For both products, the FEEDAP Panel has concerns regarding the safety for the target species when the additives are administered via feed and water for drinking, simultaneously. In the absence of data, the FEEDAP Panel cannot conclude on the safety of both forms of the additive for the user. The products under assessment are considered efficacious sources of the amino acid l-lysine for all animal species. For these products to be as efficacious in ruminants as in non-ruminant species, they require protection against degradation in the rumen.
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]Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on concentrated liquid l-lysine (base) and l-lysine monohydrochloride (HCl) produced using Corynebacterium casei KCCM 80190 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l-lysine. The production strain is genetically modified. It does not carry acquired antimicrobial resistance genes and no viable cells of the production strain nor its DNA were detected in the final products. Therefore, the additives do not pose any safety concern regarding the genetic modifications. Concentrated liquid l-lysine (base) and l-lysine HCl produced by C. casei KCCM 80190 do not represent a risk for the target species, the consumer and the environment. From the results of studies on the safety for the user of concentrated liquid l-lysine (base) and l-lysine HCl produced by a different production strain, it was possible to conclude on the safety for the user of the products under assessment. Concentrated liquid l-lysine (base) produced by C. casei KCCM 80190 is considered hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. l-Lysine HCl produced by C. casei KCCM 80190 is considered hazardous by inhalation, it is not irritant to skin but mildly irritant to eyes and it is not a skin sensitiser. Concentrated liquid l-lysine (base) and l-lysine HCl are considered efficacious sources of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.