SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure
Kazakhstan260 participantsStarted 2026-06
Plain-language summary
The SURE-HF trial is a pragmatic, multicentre, randomized controlled study evaluating natriuresis-guided optimization of intravenous loop diuretic therapy in patients hospitalized with worsening heart failure (WHF). The study aims to determine whether serial urinary sodium assessment combined with a structured decongestive treatment algorithm improves decongestion, reduces the need for therapy escalation, and enhances discharge readiness compared with standard care.
Participants will be randomized to standard urine output-guided therapy or natriuresis-guided decongestive strategies using different intravenous loop diuretic administration regimens. The study integrates bedside diagnostic tools including lung ultrasound, inferior vena cava assessment, focused echocardiography, and serial clinical congestion monitoring.
The primary endpoint is a hierarchical composite outcome including escalation of heart failure therapy, persistent congestion at discharge, inability to transition to oral loop diuretics by Day 5, and residual ultrasound congestion. The findings of the SURE-HF trial may support implementation of urinary sodium-guided and ultrasound-assisted decongestive therapy in routine heart failure management.
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.
* Confirmed diagnosis of worsening heart failure (WHF), characterized by symptoms and signs of acute decompensation requiring hospitalization for intensification of intravenous diuretic therapy.
* Previous intake of a loop diuretic (torasemide or furosemide) in any dose for at least 2 days before hospitalization.
* Presence of clinical signs and symptoms of congestion (e.g., dyspnea, orthopnea, peripheral edema, pulmonary congestion).
* Provision of written informed consent.
Exclusion Criteria:
* Acute coronary syndrome within the previous 30 days.
* Acute heart failure requiring urgent invasive intervention, including cardiogenic shock or mechanical circulatory support.
* Current admission to an intensive care unit.
* Systolic blood pressure ≤90 mmHg or requirement for inotropic/vasopressor support.
* Recent use (≤48 hours) of inotropic agents affecting fluid and electrolyte balance.
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or requirement for renal replacement therapy.
* Hypokalemia (\<3.5 mmol/L) or hyperkalemia (≥5.5 mmol/L).
* Clinically significant hyponatremia (\<130 mmol/L) or hypernatremia (\>150 mmol/L).
* Significant comorbidities affecting sodium-water balance (e.g., liver cirrhosis with ascites, nephrotic syndrome, severe infection or sepsis).
* Pregnancy or breastfeeding.
* Active malignancy.
* Inability to comply with the study protocol or participation in another interventional clinical trial.
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.
1Since this trial is 'not yet recruiting,' how long might it be before I could actually enroll, and is there a standard treatment approach for my worsening heart failure that I should pursue in the meantime?
2This trial is testing whether adjusting diuretic doses based on urine sodium levels works better than usual care for heart failure congestion — can you explain how my current diuretic management compares to what this study is testing, and whether that approach might already make sense for me?
3The main outcome being measured is something called 'unsuccessful decongestion' — what does that mean in practical terms for a patient like me, and how would doctors in this trial decide if my congestion is or isn't being successfully treated?
4Since this trial doesn't list a specific phase, what does that tell us about how much is already known about the safety and effectiveness of urine sodium-guided diuretic therapy, and are there published studies I should ask you about?
5Given that this study focuses on worsening heart failure and congestion, how does my current symptom severity fit with what this trial seems to be targeting, and are there other trials or guideline-based treatments I should consider at the same time?
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.
What they're measuring
1
Hierarchical Composite Endpoint of Unsuccessful Decongestion
Timeframe: From randomization through hospital discharge, assessed up to 14 days.