Status:
COMPLETED
Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 h...
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 f...
Eligibility Criteria
Inclusion
- Meticulous history of medical compliance and attendance of appointments
- Stable heart failure as defined by:
- Absence of hospitalizations for 90 days
- Stable diuretic and medical therapy for 30 days
- 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
- 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
- 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
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03440970
Start Date
January 15 2019
End Date
August 30 2025
Last Update
September 15 2025
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06510