Status:
COMPLETED
Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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.
Detailed Description
The overarching goal of this proposal is to develop a comprehensive understanding of the biology and therapeutic potential of sodium-free chloride supplementation. While sodium homeostasis has been th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03446651
Start Date
July 12 2018
End Date
September 7 2022
Last Update
January 30 2024
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06510