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NCT03446651

Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure

Completed EARLY_PHASE1 Results posted Last updated 30 January 2024
What this trial tests

EARLY_PHASE1 trial testing Lysine Chloride in Heart Failure in 50 participants. Completed in 7 September 2022.

Timeline
12 July 2018
Primary endpoint
7 September 2022
7 September 2022

Quick facts

Lead sponsorYale University
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposediagnostic
Enrollment50
Start date12 July 2018
Primary completion7 September 2022
Estimated completion7 September 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Blood Volume Primary · Daily for 7 days

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.

GroupValue95% CI
Lysine Chloride-320± 689
Placebo-447± 520
Change in Serum Creatinine Secondary · Daily for 7-days

A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of serum creatinine will be compared across the 7 day collection period between intervention and placebo arms.

GroupValue95% CI
Lysine Chloride0.00-0.04 – 0.04
Placebo0.040.02 – 0.06
Change in Chloride Secondary · Daily for 7-days

A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of chloride will be compared across the 7 day collection period between intervention and placebo arms.

GroupValue95% CI
Lysine Chloride0.710.36 – 1.06
Placebo-0.87-1.32 – -0.43
Change in Bicarbonate Secondary · Daily for 7-days

A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of bicarbonate will be compared across the 7 day collection period between intervention and placebo arms.

GroupValue95% CI
Lysine Chloride-1.02-1.35 – -0.70
Placebo0.19-0.16 – 0.55

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 7 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lysine Chloride
Serious: 0/22 (0%)
Deaths: 0/22
Placebo
Serious: 0/18 (0%)
Deaths: 0/18
Other adverse events (9 terms — click to expand)

ReactionSystemLysine ChloridePlacebo
DiarrheaGastrointestinal disorders
Renal failureRenal and urinary disorders
HypotensionVascular disorders
Acute kidney injuryRenal and urinary disorders
Metabolic acidosis without acidemiaMetabolism and nutrition disorders
HypokalemiaMetabolism and nutrition disorders
GI bloatingGastrointestinal disorders
CellulitisInfections and infestations
GoutGeneral disorders

Data from ClinicalTrials.gov NCT03446651 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. "I don't get no respect": the role of chloride in acute kidney injury.
    Rein JL, Coca SG. · · 2019 · cited 60× · PMID 30539650 · DOI 10.1152/ajprenal.00130.2018
  2. Hypochloraemia in Patients with Heart Failure: Causes and Consequences.
    Cuthbert JJ, Bhandari S, Clark AL. · · 2020 · cited 30× · PMID 32772346 · DOI 10.1007/s40119-020-00194-3
  3. Hypochloraemia and 30 day readmission rate in patients with acute decompensated heart failure.
    Marchenko R, Sigal A, Wasser TE, Reyer J, et al · · 2020 · cited 19× · PMID 32286008 · DOI 10.1002/ehf2.12587
  4. Combination Diuretic Therapy to Counter Renal Sodium Avidity in Acute Heart Failure: Trials and Tribulations.
    Kazory A. · · 2023 · cited 8× · PMID 37102974 · DOI 10.2215/cjn.0000000000000188

Verify or expand the search:

Other trials of Lysine Chloride

Trials testing the same drug.

Other recruiting trials for Heart Failure

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing