Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03440970
Other study ID # 2000022016
Secondary ID 1R01HL139629-01
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 15, 2019
Est. completion date June 2025

Study information

Verified date June 2024
Source Yale University
Contact Katherine Keith
Phone 8602273925
Email katherine.keith@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - Ejection fraction <40% - 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 outpatient or inpatient 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 inpatient 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 - 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 >100 mL - Use of chloride containing medications that provide more than 5 mmol/day of chloride if the medication cannot be discontinued or substituted - Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research RN (ex: clinically-significant psychiatric, addictive, or neurological disease) - Inability to give written informed consent or follow study protocol

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lysine Chloride
Patients will receive the study drug twice a day for 5 days.
Other:
Placebo
Patients will receive the placebo twice a day for 5 days.

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in log NTpro-BNP N-terminal prohormone of brain natriuretic peptide (NTpro-BNP) is used to screen and diagnosis of acute congestive heart failure (CHF) and can be used to establish prognosis in heart failure. A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of NTpro-BNP will be compared across the 7 day collection period between intervention and placebo arms. Daily for 7-days
Secondary Change in Serum Creatinine 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. Daily for 7-days
Secondary Change in Cystatin C A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of cystatin C will be compared across the 7 day collection period between intervention and placebo arms. Daily for 7-days
Secondary Change in Chloride 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. Daily for 7-days
Secondary Change in Bicarbonate 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. Daily for 7-days
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05910437 - Optimizing Treatments for Heart Failure During Hospitalization
Terminated NCT00355017 - BNP Guided Care in Addition to Multidisciplinary Care N/A
Active, not recruiting NCT03701880 - Early Use of Ivabradine in Heart Failure N/A
Recruiting NCT03157219 - Manipal Heart Failure Registry (MHFR) N/A
Recruiting NCT06114498 - Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
Completed NCT03838003 - Exercise in Patients Admitted With Recently Decompensated Heart Failure N/A
Completed NCT02997462 - Monocyte Phenotypic Changes in Heart Failure
Completed NCT04493346 - Shear Wave Elastography
Recruiting NCT02666651 - Regional Tolvaptan Registry Phase 4
Recruiting NCT02236247 - Control of Sinus Node Tachycardia as an Additional Therapy in Patients With Decompensated Heart Failure Phase 1/Phase 2
Not yet recruiting NCT06273397 - Acetazolamide or Metolazone in Acute Heart Failure N/A
Completed NCT05927285 - Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1 N/A
Withdrawn NCT04572867 - Aquapheresis Efficacy in Outpatients With Decompensated Heart Failure N/A
Completed NCT02157506 - A Dose Ranging Phase IIa Study of 6 Hour Intravenous Dosages of CXL-1427 in Patients Hospitalized With Heart Failure Phase 2
Recruiting NCT03914222 - Comparing PA Compliance During and After Decompensation in HFP N/A
Recruiting NCT06286423 - Colchicine in Acutely Decompensated HFREF Phase 4
Recruiting NCT03009552 - Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure N/A
Completed NCT04019314 - Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI) N/A
Recruiting NCT02649517 - Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction N/A
Recruiting NCT05090930 - Innovative Technologies for the Treatment of Pulmonary and Heart Failure N/A