Decompensated Heart Failure Clinical Trial
Official title:
Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 - Ejection fraction <40% - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Blood Volume | Volumex is albumin labeled with the iodine isotope I-131 and is an FDA-approved method used to determine total blood volume. A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of blood collection will be compared across the 7 day collection period between intervention and placebo arms. | Daily for 7-days | |
Secondary | Change in log NTpro-BNP | N-terminal prohormone of brain natriuretic peptide (NTpro-BNP) is used to screen and diagnosis of acute congestive heart failure (CHF) and can be used to establish prognosis in heart failure. A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of NTpro-BNP will be compared across the 7 day collection period between intervention and placebo arms. | Daily for 7-days | |
Secondary | Change in Serum Creatinine | A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of serum creatinine will be compared across the 7 day collection period between intervention and placebo arms. | Daily for 7-days | |
Secondary | Change in Cystatin C | A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of cystatin C will be compared across the 7 day collection period between intervention and placebo arms. | Daily for 7-days | |
Secondary | Change in Chloride | A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of chloride will be compared across the 7 day collection period between intervention and placebo arms. | Daily for 7-days | |
Secondary | Change in Bicarbonate | A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of bicarbonate will be compared across the 7 day collection period between intervention and placebo arms. | Daily for 7-days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05910437 -
Optimizing Treatments for Heart Failure During Hospitalization
|
||
Terminated |
NCT00355017 -
BNP Guided Care in Addition to Multidisciplinary Care
|
N/A | |
Active, not recruiting |
NCT03701880 -
Early Use of Ivabradine in Heart Failure
|
N/A | |
Recruiting |
NCT03157219 -
Manipal Heart Failure Registry (MHFR)
|
N/A | |
Recruiting |
NCT06114498 -
Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
|
||
Completed |
NCT03838003 -
Exercise in Patients Admitted With Recently Decompensated Heart Failure
|
N/A | |
Completed |
NCT02997462 -
Monocyte Phenotypic Changes in Heart Failure
|
||
Completed |
NCT04493346 -
Shear Wave Elastography
|
||
Recruiting |
NCT02666651 -
Regional Tolvaptan Registry
|
Phase 4 | |
Recruiting |
NCT02236247 -
Control of Sinus Node Tachycardia as an Additional Therapy in Patients With Decompensated Heart Failure
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06273397 -
Acetazolamide or Metolazone in Acute Heart Failure
|
N/A | |
Completed |
NCT05927285 -
Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1
|
N/A | |
Withdrawn |
NCT04572867 -
Aquapheresis Efficacy in Outpatients With Decompensated Heart Failure
|
N/A | |
Completed |
NCT02157506 -
A Dose Ranging Phase IIa Study of 6 Hour Intravenous Dosages of CXL-1427 in Patients Hospitalized With Heart Failure
|
Phase 2 | |
Recruiting |
NCT03914222 -
Comparing PA Compliance During and After Decompensation in HFP
|
N/A | |
Recruiting |
NCT06286423 -
Colchicine in Acutely Decompensated HFREF
|
Phase 4 | |
Recruiting |
NCT03009552 -
Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure
|
N/A | |
Completed |
NCT04019314 -
Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI)
|
N/A | |
Recruiting |
NCT02649517 -
Clinical and Morphological Characteristics of Chronic Inflammation in the Myocardium in Patients With Decompensated HF With Ischemic Systolic Dysfunction
|
N/A | |
Recruiting |
NCT05090930 -
Innovative Technologies for the Treatment of Pulmonary and Heart Failure
|
N/A |