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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 is studying whether adding chloride to diuretic therapy may improve heart failure symptoms in patients who are volume-overloaded.
Who is the study for?
This trial is for adults with acute heart failure showing signs like rales, edema, or weight gain. They must be on chronic loop diuretics and need IV diuretics as judged by their doctor. Excluded are those who can't commit to follow-up visits, have had severe acidosis recently, have certain kidney issues or use drugs that risk acidosis.Check my eligibility
What is being tested?
The study aims to see if giving chloride (as Lysine Chloride) helps patients with acute heart failure who are already getting IV diuretics. Some will get the real treatment while others will receive a placebo to compare outcomes.See study design
What are the potential side effects?
Potential side effects of Lysine Chloride may include changes in blood acidity levels and electrolyte imbalances which could affect organ function. The exact side effects aren't listed but would relate to chloride metabolism.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily for 7-days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily for 7-days
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
Change in Chloride
Change in Cystatin C
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lysine ChlorideExperimental Treatment1 Intervention
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
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?
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,478 Total Patients Enrolled
32 Trials studying Heart Failure
55,949 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,446 Total Patients Enrolled
206 Trials studying Heart Failure
677,398 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a very serious problem with the balance of acids in your body or with your breathing within the last 30 days.Your blood bicarbonate level is less than 20mmol/L.Your kidneys are not working well, or you are on kidney replacement therapy.You have been diagnosed with severe heart failure and show signs of fluid buildup in your body, such as swelling, abnormal sounds in your lungs, or weight gain.You are regularly taking a certain type of water pill called a "loop diuretic."You are taking certain medications that may cause a condition called acidosis. If you are taking metformin, you may still be able to join the study if you can stop taking it safely. Also, if you consistently have high blood sugar while in the hospital, you cannot join the study.Your doctor thinks you will need to keep receiving IV diuretics during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Lysine Chloride
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for prospective participants in this experiment?
"According to the data presented on clinicaltrials.gov, this investigation into a novel medical treatment is still seeking participants and has been updated recently - July 12th 2018 being the initial post date and July 20th 2022 being most recent change."
Answered by AI
What health conditions is Lysine Chloride commonly utilized to address?
"Lysine Chloride is usually utilized to supplement dietary amino acid levels. Additionally, it can be effective at treating symptoms of anorexia nervosa such as loss of appetite and poor diet intake."
Answered by AI
How many people are participating in the current clinical experiment?
"Affirmative, the information published on clinicaltrials.gov shows that this trial is currently open for recruitment. It was first posted on July 12th 2018 and most recently updated early last month (July 20th 2022). This research endeavour needs to find 125 participants at a single medical site."
Answered by AI
To what extent has Lysine Chloride been explored in other scientific investigations?
"Presently, there are 99 active clinical trials for Lysine Chloride with 36 of those studies at Phase 3. Of the 19721 research sites hosting these experiments, many are situated in Los Angeles County."
Answered by AI
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