Lysine Chloride for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effects of lysine chloride, a sodium-free chloride supplement, on patients with stable heart failure. Researchers aim to understand its impact on electrolyte balance and overall fluid levels in the body. Participants will receive either lysine chloride or a placebo three times a day for five days. The trial seeks individuals with heart failure who have not been hospitalized in the past 90 days, are on stable medication, and have a low serum chloride level. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lysine chloride is generally safe for humans. Studies have found that ʟ-lysine hydrochloride, similar to lysine chloride, is well-tolerated by people. It has been used in dietary supplements at doses up to 3.75 grams per day without causing major side effects. Additionally, taking lysine supplements usually does not lead to many negative effects. This suggests that lysine chloride might be safe to use. However, since this trial is in an early stage, researchers are closely monitoring it to ensure safety.12345
Why do researchers think this study treatment might be promising for heart failure?
Lysine chloride is unique because it offers a new approach to treating heart failure by potentially impacting blood volume management. Unlike the standard treatments, which often focus on improving heart function or reducing symptoms through medications like beta-blockers and ACE inhibitors, lysine chloride might work by directly influencing the body's fluid balance. Researchers are excited about this treatment because it could provide a quicker, more effective way to relieve symptoms of heart failure, with patients possibly seeing benefits within just days of starting therapy. If successful, this could represent a significant advancement in managing heart failure, offering hope to patients who need faster relief.
What evidence suggests that lysine chloride might be an effective treatment for heart failure?
This trial will compare Lysine Chloride with a placebo to evaluate its effects on heart failure. Research has shown that lysine supplements may benefit heart health. One study found that lysine improved the heart and blood vessels' ability to handle stress, suggesting it could support heart health by managing stress. Lysine is also safe for consumption, even in larger amounts. While this trial continues to investigate Lysine Chloride for heart failure, these early findings are promising and suggest it might help improve heart function.12678
Who Is on the Research Team?
Jeffrey M Testani, MD
Principal Investigator
Yale University
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lysine chloride or placebo twice a day for 5 days after a blood volume assessment
Follow-up
Participants are monitored for changes in blood volume, NTpro-BNP, chloride, serum creatinine, cystatin C, and bicarbonate
What Are the Treatments Tested in This Trial?
Interventions
- Lysine Chloride
- Placebo
Lysine Chloride is already approved in United States, European Union, Japan, India for the following indications:
- Herpes simplex prophylaxis and treatment
- Lysinuric protein intolerance
- Nephroprotection
- Herpes simplex prophylaxis and treatment
- Lysinuric protein intolerance
- Nephroprotection
- Schizophrenia
- Herpes simplex prophylaxis and treatment
- Anxiety
- 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
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator