Worsening Heart FailureSURE-HFNCT07631780
SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure
A study testing Furosemide and Horiba LAQUAtwin B-722 in people with Worsening Heart Failure and Congestion, run by Nurgul Ablakimova at 1 site in Kazakhstan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Worsening Heart Failure, Congestion, Heart Failure
- What is being tested?
- Furosemide and Horiba LAQUAtwin B-722
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteKazakhstan
- Study dates
- Jun 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site
West Kazakhstan Marat Ospanov Medical University
Aktobe, 030000
Ayagoz Meshitbayeva, 77714040296, ayagozmeshitbayeva@gmail.com
About this study
Official title: Urinary Sodium-Guided Optimization of Diuretic Therapy in Patients With Worsening Heart Failure: Rationale and Design of a Pragmatic Randomized Controlled Trial (SURE-HF Trial)
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.
- Conditions
- Worsening Heart Failure, Congestion, Heart Failure
- Being tested
- Furosemide, Horiba LAQUAtwin B-722
- Keywords
- Worsening Heart Failure, Congestion, Natriuresis, Urinary Sodium, Diuretic Therapy, Loop Diuretics, Decongestion, Fluid Overload, Bedside Diagnostics
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
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.
Horiba LAQUAtwin B-722Device
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Standard urine output-guided decongestive therapy according to institutional practice and predefined treatment protocols. Receives: Drug: Furosemide |
| 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. Receives: Drug: Furosemide; Device: Horiba LAQUAtwin B-722 |
| 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. Receives: Drug: Furosemide; Device: Horiba LAQUAtwin B-722 |
| Natriuresis-Guided Prolonged Intermittent Infusion | Experimental | Natriuresis-guided decongestive therapy using prolonged intermittent intravenous furosemide infusion with dose titration based on urinary sodium assessment. Receives: Drug: Furosemide; Device: Horiba LAQUAtwin B-722 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical Composite Endpoint of Unsuccessful Decongestion
- Escalation of heart failure therapy within the first 5 days of hospitalization.
- Persistent clinical congestion at hospital discharge, defined as the presence of at least two of the following: dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, or elevated jugular venous pressure.
- Failure to transition from intravenous to oral loop diuretics by Day 5 of hospitalization.
- Residual ultrasound congestion at hospital discharge, defined as ≥1 zone with ≥3 B-lines (one positive zone) on each hemithorax using 8-zone scanning
Measured: From randomization through hospital discharge, assessed up to 14 days.
Secondary outcomes (6)
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.
Measured: 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
Time to Clinical Decongestion
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.
Measured: 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.
Measured: 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.
Measured: From hospital discharge through 30 days after discharge.
Cumulative Urine Output
Total urine output measured during hospitalization.
Measured: 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.
Measured: Within 72 hours after initiation of intravenous loop diuretic therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Worsening Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurgul Ablakimova
- Sponsor type
- University, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Responsible party
- Sponsor-investigator, Nurgul Ablakimova, West Kazakhstan Marat Ospanov Medical University
- Investigators
- Nurgul Ablakimova, PhD, Principal investigator, West Kazakhstan Marat Ospanov Medical UniversityVadim Medovchshikov, PhD, Study director, West Kazakhstan Marat Ospanov Medical UniversityAnzhela Soloveva, candidate of medical sciences, Principal investigator, I.M. Sechenov First Moscow State Medical UniversitySvetlana Rachina, doctor of medical sciences, Study chair, I.M. Sechenov First Moscow State Medical UniversityGaziza Smagulova, candidate of medical sciences, Study chair, West Kazakhstan Marat Ospanov Medical UniversityAyagoz Meshitbayeva, Principal investigator, West Kazakhstan Marat Ospanov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631780
- Sponsor's protocol ID
- 13/2-19-38-7
- Other IDs
- Order №13/2-19-38-7
- Acronym
- SURE-HF
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34791756Mullens 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.
PubMed 30600580McDonagh 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.
PubMed 34447992
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Sodium-Guided Optimization of Diuretic Therapy in Patients With Worsening Heart Failure: Rationale and Design of a Pragmatic Randomized Controlled Trial (SURE-HF Trial)
- ClinicalTrials.gov ID
- NCT07631780
- Acronym / sponsor ID
- SURE-HF / 13/2-19-38-7
- Conditions
- Worsening Heart Failure, Congestion, Heart Failure
- Keywords
- Worsening Heart Failure, Congestion, Natriuresis, Urinary Sodium, Diuretic Therapy, Loop Diuretics, Decongestion, Fluid Overload
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Nurgul AblakimovaUniversity, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Drug: FurosemideStandard urine output-guided decongestive therapy according to institutional practice and predefined treatment protocols. |
| Natriuresis-Guided Intermittent IV Bolus | Experimental | Drug: Furosemide, Device: Horiba LAQUAtwin B-722Natriuresis-guided decongestive therapy using intermittent intravenous bolus administration of furosemide with dose titration based on urinary sodium assessment. |
| Natriuresis-Guided Continuous Infusion | Experimental | Drug: Furosemide, Device: Horiba LAQUAtwin B-722Natriuresis-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 | Drug: Furosemide, Device: Horiba LAQUAtwin B-722Natriuresis-guided decongestive therapy using prolonged intermittent intravenous furosemide infusion with dose titration based on urinary sodium assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideIntravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration. | Drug | Natriuresis-Guided Continuous Infusion, Natriuresis-Guided Intermittent IV Bolus, Natriuresis-Guided Prolonged Intermittent Infusion, Standard Treatment |
| Horiba LAQUAtwin B-722Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy. | Device | Natriuresis-Guided Continuous Infusion, Natriuresis-Guided Intermittent IV Bolus, Natriuresis-Guided Prolonged Intermittent Infusion |
Primary outcome
Hierarchical Composite Endpoint of Unsuccessful Decongestion
Time frame: From randomization through hospital discharge, assessed up to 14 days.
1. Escalation of heart failure therapy within the first 5 days of hospitalization. 2. Persistent clinical congestion at hospital discharge, defined as the presence of at least two of the following: dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, or elevated jugular venous pressure. 3. Failure to transition from intravenous to oral loop diuretics by Day 5 of hospitalization. 4. Residual ultrasound congestion at hospital discharge, defined as ≥1 zone with ≥3 B-lines (one positive zone) on each hemithorax using 8-zone scanning
6 secondary outcomes
Total and Time-Specific Urinary Sodium Excretion
Time frame: 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
Time to Clinical Decongestion
Time frame: From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.
Length of Hospital Stay
Time frame: From hospital admission to hospital discharge, assessed up to 30 days.
Death or Heart Failure Rehospitalization Within 30 Days After Discharge
Time frame: From hospital discharge through 30 days after discharge.
Cumulative Urine Output
Time frame: From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.
Proportion of Patients Achieving Predefined Natriuresis Targets
Time frame: Within 72 hours after initiation of intravenous loop diuretic therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 34791756Ter 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.
- Background: PubMed 30600580Mullens 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.
- Background: PubMed 34447992McDonagh 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
West Kazakhstan Marat Ospanov Medical University
Aktobe, Kazakhstan
Nurgul Ablakimova, PhD principal investigator
West Kazakhstan Marat Ospanov Medical University
Vadim Medovchshikov, PhD study director
West Kazakhstan Marat Ospanov Medical University
Anzhela Soloveva, candidate of medical sciences principal investigator
I.M. Sechenov First Moscow State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide and Horiba LAQUAtwin B-722 in people with Worsening Heart Failure and Congestion, run by Nurgul Ablakimova at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical Composite Endpoint of Unsuccessful Decongestion (time frame: From randomization through hospital discharge, assessed up to 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07631780, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.