COMPLETED

Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure

Conditions

Decompensated Heart Failure Chloride homeostasisH

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure

Quick Facts

Study Start:2019-01-15

Study Completion:2025-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03440970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Jeffrey M Testani, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Yale University

Jeffrey M Testani, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-15

Study Completion Date2025-08-30

Study Record Updates

Study Start Date2019-01-15

Study Completion Date2025-08-30

Terms related to this study

Keywords Provided by Researchers

Chloride homeostasisH

Additional Relevant MeSH Terms

Decompensated Heart Failure