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| ID | Type | Description | Link |
|---|---|---|---|
| Order â„–13/2-19-38-7 | Other Grant/Funding Number | West Kazakhstan Marat Ospanov medical university |
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| Name | Class |
|---|---|
| I.M. Sechenov First Moscow State Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Active Comparator | Standard urine output-guided decongestive therapy according to institutional practice and predefined treatment protocols. |
|
| Natriuresis-Guided Intermittent IV Bolus | Experimental | Natriuresis-guided decongestive therapy using intermittent intravenous bolus administration of furosemide with dose titration based on urinary sodium assessment. |
|
| Natriuresis-Guided Continuous Infusion | Experimental | Natriuresis-guided decongestive therapy using continuous intravenous furosemide infusion via infusion pump with dose titration based on urinary sodium assessment. |
|
| Natriuresis-Guided Prolonged Intermittent Infusion | Experimental | Natriuresis-guided decongestive therapy using prolonged intermittent intravenous furosemide infusion with dose titration based on urinary sodium assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration. |
| Measure | Description | Time Frame |
|---|---|---|
| Hierarchical Composite Endpoint of Unsuccessful Decongestion |
| From randomization through hospital discharge, assessed up to 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Total and Time-Specific Urinary Sodium Excretion | Urinary sodium excretion measured at 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy. | 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy. |
| Time to Clinical Decongestion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Symptomatic Hypotension | Occurrence of symptomatic hypotension during hospitalization. | From randomization through hospital discharge, assessed up to 14 days. |
| Clinically Significant Electrolyte Disturbances |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nurgul Ablakimova, PhD | West Kazakhstan Marat Ospanov Medical University | Principal Investigator |
| Vadim Medovchshikov, PhD | West Kazakhstan Marat Ospanov Medical University | Study Director |
| Anzhela Soloveva, candidate of medical sciences | I.M. Sechenov First Moscow State Medical University | Principal Investigator |
| Svetlana Rachina, doctor of medical sciences | I.M. Sechenov First Moscow State Medical University | Study Chair |
| Gaziza Smagulova, candidate of medical sciences | West Kazakhstan Marat Ospanov Medical University | Study Chair |
| Ayagoz Meshitbayeva | West Kazakhstan Marat Ospanov Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Kazakhstan Marat Ospanov Medical University | Aktobe | 030000 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34791756 | Background | Ter Maaten JM, Beldhuis IE, van der Meer P, Krikken JA, Coster JE, Nieuwland W, van Veldhuisen DJ, Voors AA, Damman K. Natriuresis-guided therapy in acute heart failure: rationale and design of the Pragmatic Urinary Sodium-based treatment algoritHm in Acute Heart Failure (PUSH-AHF) trial. Eur J Heart Fail. 2022 Feb;24(2):385-392. doi: 10.1002/ejhf.2385. Epub 2022 Jan 6. | |
| 30600580 |
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De-identified individual participant data underlying the reported results may be shared upon reasonable request to the corresponding author following publication of the primary study results, subject to institutional approval and applicable data protection regulations.
De-identified individual participant data and supporting documents will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Access to de-identified individual participant data and supporting documents will be provided to qualified researchers upon reasonable request to the corresponding author and after approval by the study investigators and participating institution. Data sharing will be limited to non-commercial scientific research purposes and subject to applicable ethical and data protection requirements.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004487 | Edema |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Participants will be randomized in a parallel-group design to receive either standard urine output-guided therapy or natriuresis-guided decongestive therapy using one of the predefined intravenous furosemide administration regimens. Treatment will be delivered according to the assigned study arm throughout the index hospitalization.
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Due to the nature of the intervention, the study is conducted in an open-label design. Urinary sodium measurements in the standard-of-care group will remain concealed from treating physicians and will not be used for protocol-driven treatment adjustment. Whenever feasible, investigators responsible for outcome assessment and statistical analysis will remain blinded to treatment allocation.
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| Horiba LAQUAtwin B-722 | Device | Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy. |
|
Time from initiation of intravenous loop diuretic therapy to achievement of clinical decongestion, defined as resolution of clinical signs and symptoms of congestion, including absence of dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, and elevated jugular venous pressure. |
| From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days. |
| Length of Hospital Stay | Duration of hospitalization measured as the number of days from hospital admission to hospital discharge. | From hospital admission to hospital discharge, assessed up to 30 days. |
| Death or Heart Failure Rehospitalization Within 30 Days After Discharge | Composite outcome of all-cause mortality or rehospitalization due to worsening heart failure occurring within 30 days after hospital discharge. | From hospital discharge through 30 days after discharge. |
| Cumulative Urine Output | Total urine output measured during hospitalization. | From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days. |
| Proportion of Patients Achieving Predefined Natriuresis Targets | Proportion of patients achieving predefined urinary sodium excretion targets according to the study treatment algorithm during the first 72 hours of hospitalization. | Within 72 hours after initiation of intravenous loop diuretic therapy. |
Occurrence of clinically significant abnormalities in serum potassium or sodium during hospitalization.
| From baseline through hospital discharge, assessed up to 14 days. |
| All-Cause In-Hospital Mortality | Death from any cause occurring during hospitalization. | From randomization through hospital discharge, assessed up to 14 days. |
| Background |
| Mullens W, Damman K, Harjola VP, Mebazaa A, Brunner-La Rocca HP, Martens P, Testani JM, Tang WHW, Orso F, Rossignol P, Metra M, Filippatos G, Seferovic PM, Ruschitzka F, Coats AJ. The use of diuretics in heart failure with congestion - a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019 Feb;21(2):137-155. doi: 10.1002/ejhf.1369. Epub 2019 Jan 1. |
| 34447992 | Background | McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |