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COMPLETEDEARLY_PHASE1

Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure

NCT03440970•Yale University

Summary

This study is designed to investigate the quantitative effects of sodium-free chloride supplementation on electrolyte balance, volume status, and sodium avidity in stable heart failure patients in a highly controlled environment.

Detailed Description

The overarching goal of this study is to develop a comprehensive understanding of the biology and therapeutic potential of sodium-free chloride supplementation. While sodium homeostasis has been the focus of substantial investigation, very little research has been devoted to understanding chloride homeostasis. Thus, this proposal is designed to obtain the full spectrum of information pertaining to chloride, such as novel areas with great interest by the scientific community (i.e. modulation of the WNK-kinase system and the use of exosomes), to more practical/basic questions (i.e. what happens to sodium chloride balance when a patient is challenged with chloride). This study is designed as a highly controlled inpatient "GCRC" arm to be compared to a real world efficacy study that has been proposed as a separate study. With extensive biobanking and analysis of samples in the inpatient setting, we will be able to deliver a great wealth of information on the biology and therapeutic potential of manipulating chloride homeostasis in heart failure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meticulous history of medical compliance and attendance of appointments
•Stable heart failure as defined by:
•1. Absence of hospitalizations for 90 days
•2. Stable diuretic and medical therapy for 30 days
•3. Opinion of the patient's treating physician (Heart Failure Cardiologist) that the patient is at optimal volume status
•Evidence based heart failure treatment with maximally-tolerated doses of a beta blocker, ACE/ARB/neprilysin inhibitor and aldosterone antagonist
•Chronic loop diuretic therapy with ≥ 40 mg of furosemide equivalents
•Serum chloride \<102 mmol/L

Exclusion Criteria

•Inability to commit to or comply with the rigorous study protocol
•Use of a thiazide diuretic in the last 30 days
•History of metabolic or respiratory acidosis
•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 safely discontinued for the randomized periods in each arm. Any participants who have consistently elevated Blood glucose readings \> 200 mg/dL while inpatient will not be enrolled.
•Serum bicarbonate level \<24mmol/L
•Serum pH \<7.3
•Estimated glomerular filtration rate \<30 mL/min or prior or current history of renal replacement therapy
•Anemia, as defined by Hemoglobin \<8.0 g/dL at screening visit
•Urinary incontinence or significant bladder dysfunction (post-void residual at screening \>300 mL)
•Use of chloride containing medications that provide more than 5 mmol/day of chloride if the medication cannot be discontinued or substituted
+2 more criteria

Locations (1)

Yale University

New Haven, Connecticut, United States

Key Dates

Start Date

January 15, 2019

Primary Completion Date

August 30, 2025

Completion Date

August 30, 2025

Last Updated

September 15, 2025

Enrollment

ACTUAL participants

Conditions

Decompensated Heart Failure

Interventions

Lysine Chloride

DRUG

Placebo

OTHER

Add-on Diuretics in Acute Decompensated Heart Failure

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Acute Decompensated Heart Failure

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RECRUITINGNA

Use of Point-of-Care Ultrasound (POCUS) to Reduce Hospital Length of Stay in Patients With Heart Failure ( POCUSHF )

NCT06965712

Heart FailureDecompensated Heart Failure+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure

Inclusion Criteria

Exclusion Criteria

Add-on Diuretics in Acute Decompensated Heart Failure

Use of Point-of-Care Ultrasound (POCUS) to Reduce Hospital Length of Stay in Patients With Heart Failure ( POCUSHF )

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure

EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

Adherence to Medication in Patients With Acute Decompensated Heart Failure