Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure

Launched by YALE UNIVERSITY · Feb 14, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at how adding sodium-free chloride to the diet of patients with stable heart failure can affect their overall health, specifically focusing on electrolyte balance and fluid management. The researchers want to understand how this addition might help improve heart function and overall well-being in patients who have not been hospitalized for 90 days and are currently stable on their heart failure medications.

To participate in this study, potential participants need to be between 65 and 74 years old, have a specific type of heart failure with a reduced heart pumping ability (known as ejection fraction less than 40%), and have been on certain heart medications. Those who join the study will be closely monitored and will need to follow a strict protocol, which may involve both outpatient and inpatient visits. It's important for participants to be committed to attending appointments and following the study guidelines. This trial is currently recruiting, and those interested should speak with their healthcare provider to see if they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• 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 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