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Electrolyte Supplement

Lysine Chloride for Heart Failure

Phase < 1
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for 7-days
Awards & highlights

Study Summary

This trial will study the effects of a salt-free diet on heart failure patients.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include imbalances in electrolytes leading to muscle cramps or weakness, digestive disturbances such as nausea or diarrhea from lysine chloride supplementation, and possible interactions with other medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily for 7-days
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily for 7-days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Blood Volume
Secondary outcome measures
Change in Bicarbonate
Chlorides
Change in Cystatin C
+2 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lysine Chloride
2018
Completed Early Phase 1
~70

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,607 Total Patients Enrolled
206 Trials studying Heart Failure
677,428 Patients Enrolled for Heart Failure
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,193 Total Patients Enrolled
32 Trials studying Heart Failure
55,979 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the present size of the cohort participating in this research project?

"Affirmative. According to information found on clinicaltrials.gov, this study is still recruiting participants and was initially posted in the 15th of January 2019. The last update took place on September 29th 2022 with a total of 20 patients being sought from one site."

Answered by AI

How has Lysine Chloride been employed to alleviate health issues?

"Lysine Chloride is most typically used to supplement an amino acid deficiency in patients. It can also be administered for conditions like anorexia, loss of appetite, and insufficient dietary intake."

Answered by AI

Are there extant researches concerning Lysine Chloride?

"Currently, there are 99 ongoing studies for Lysine Chloride with 36 trials in their final phase. These investigations are mainly hosted in Los Angeles, but other locations across the United States of America also have a selection of Lysine Chloride experiments underway."

Answered by AI

Are there still available slots to join this research endeavor?

"The clinical trial is actively seeking candidates, with the original posting occurring on January 15th 2019 and a recent edit taking place on September 29th 2022. This information can be found onclinicaltrials.gov."

Answered by AI
~0 spots leftby Jun 2024