Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure
2 other identifiers
interventional
50
1 country
1
Brief Summary
The purpose of this study is to understand the effects of chloride supplementation on volume-overloaded acute heart failure patients concomitantly treated with IV diuretics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 heart-failure
Started Jul 2018
Longer than P75 for early_phase_1 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2018
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedStudy Start
First participant enrolled
July 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2022
CompletedResults Posted
Study results publicly available
January 30, 2024
CompletedJanuary 30, 2024
January 1, 2024
4.2 years
February 20, 2018
December 14, 2023
January 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Blood Volume
Volumex is albumin labeled with the iodine isotope I-131 and is an FDA-approved method used to determine total blood volume. A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of blood collection will be compared across the 7 day collection period between intervention and placebo arms.
Daily for 7 days
Secondary Outcomes (5)
Change in Log NTpro-BNP
Daily for 7-days
Change in Serum Creatinine
Daily for 7-days
Change in Cystatin C
Daily for 7-days
Change in Chloride
Daily for 7-days
Change in Bicarbonate
Daily for 7-days
Study Arms (2)
Lysine Chloride
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of decompensated heart failure with at least one objective sign of volume overload (rales, edema, elevated jugular venous pressure (JVP), or weight gain of at least 5 pounds)
- A projected need by the treating clinician for continued treatment with IV diuretics
- Chronic loop diuretic use
You may not qualify if:
- Inability to commit to or comply with serial visits for treatment in the Yale Transitional Care Center (YTCC)
- History of severe metabolic or respiratory acidosis within 30 days of enrollment
- Use of metformin, acetazolamide, or any other agent that could predispose to acidosis. Patients who are on metformin may be enrolled if their metformin can be discontinued safely for the duration of the study. Any participants who have consistently elevated Blood glucose readings \> 200 mg/dL while inpatient will not be enrolled.
- Serum bicarbonate level \<20mmol/L
- Estimated glomerular filtration rate \<20 mL/min or renal replacement therapy
- Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research registered nurse (RN) (ex: clinically-significant psychiatric, addictive, or neurological disease)
- Inability to give written informed consent or follow study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Yale University
New Haven, Connecticut, 06510, United States
Related Publications (1)
Kazory A. Combination Diuretic Therapy to Counter Renal Sodium Avidity in Acute Heart Failure: Trials and Tribulations. Clin J Am Soc Nephrol. 2023 Oct 1;18(10):1372-1381. doi: 10.2215/CJN.0000000000000188. Epub 2023 Apr 27.
PMID: 37102974DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This is preliminary data analysis conducted solely for the purpose of complying with clinicaltrials.gov timelines
Results Point of Contact
- Title
- Jeffrey Testani, MD, MTR
- Organization
- Yale School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2018
First Posted
February 27, 2018
Study Start
July 12, 2018
Primary Completion
September 7, 2022
Study Completion
September 7, 2022
Last Updated
January 30, 2024
Results First Posted
January 30, 2024
Record last verified: 2024-01