SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure

N/ANot Yet RecruitingNCT07631780

Nurgul Ablakimova260 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Worsening Heart Failure Congestion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Hierarchical Composite Endpoint of Unsuccessful Decongestion

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

Time frame: From randomization through hospital discharge, assessed up to 14 days.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From hospital discharge through 30 days after discharge.

Cumulative Urine Output

Total urine output measured during hospitalization.

Time frame: 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.

Time frame: Within 72 hours after initiation of intravenous loop diuretic therapy.