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About
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.
Full 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.
Enrollment
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Inclusion criteria
Meticulous history of medical compliance and attendance of appointments
Stable heart failure as defined by:
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
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
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Central trial contact
Katherine Keith; Jeffrey M Testani
Data sourced from clinicaltrials.gov
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