Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure (NCT04334668) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Oral Sodium to Preserve Renal EfficiencY in Acute Heart Failure
United States67 participantsStarted 2020-05-20
Plain-language summary
The investigators are proposing a prospective, randomized, double blinded, placebo-controlled single center study evaluating the role of co-administration of oral sodium chloride (NaCl) with intravenous diuretics in patients hospitalized with acute decompensated heart failure. The investigators are approaching this study with the hypothesis that the use of oral sodium chloride leads to improved effective diuresis (as measured by weight loss) and renal function as compared to placebo in patients hospitalized with acute decompensated heart failure undergoing aggressive intravenous diuretic therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old AND
* Admitted to cardiology floor (non-ICU) with primary diagnosis of decompensated heart failure AND
* NT-proBNP \>1000 ng/L AND
* Initiation of continuous furosemide infusion at a rate of 10 mg/hr or higher
Exclusion Criteria:
* Serum sodium (Na+) level less than 120 or greater than 145.
* Average Systolic Blood Pressure \>180 mmHg or Diastolic Blood Pressure \>100 mmHg over past 24 hours.
* Anticipated length of stay less than 72 hours.
* Use of vasopressin antagonist
* Current use of sodium chloride tablets
* Active diagnosis of diabetes insipidus
* Inability to tolerate oral diet or swallow pills
* Presence of malabsorptive gastrointestinal disorder (Crohn's disease, short gut syndrome)
* The use of iodinated radiocontrast material in the past 72 hours or anticipated use of intravenous contrast during the current hospitalization
* Admission with intention to transplant or implant permanent Ventricular Assistive Device
* Use of intravenous inotropes, vasopressors or vasodilators at enrollment
* A baseline estimated glomerular filtration rate \<15 mL/min/1.73m² according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the moment of inclusion
* Use of renal replacement therapy at time of enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing something related to oral sodium in acute heart failure — can you explain what the study is actually doing differently with sodium, and whether that approach might be relevant to my specific situation with volume overload?
2The trial is measuring both weight change and creatinine change as its main outcomes — does that mean there's a real concern that treating my fluid overload could harm my kidney function, and how does my current kidney health factor into whether this study would even be appropriate for me?
3Since this trial is listed as 'active but no longer recruiting,' does that mean results might be available soon, and could those findings change how you'd approach my sodium or fluid management even outside of a trial setting?
4This study doesn't seem to have a traditional phase number, which I understand can mean it's more of a feasibility or pilot-type study — what does that tell us about how much is already known about the safety of this approach compared to standard treatment for volume overload?
5Would you recommend I pursue standard diuretic or fluid management treatment first, or is there a reason based on my specific case that an experimental sodium-based approach like the one in this trial might be worth waiting for or discussing further?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.