Heart Failure Acute, Renal Dysfunction
Conditions
Keywords
contrast-induced acute kidney injury, decongestion, hydration
Brief summary
The K-PROSE study is a randomized clinical investigation evaluating strategies to prevent contrast-induced acute kidney injury (CI-AKI) in patients hospitalized with acute heart failure and moderate renal dysfunction (eGFR 30-75 mL/min/1.73 m²). Patients requiring contrast-enhanced CT imaging are randomized to either standard intravenous saline hydration or a furosemide-based decongestion strategy. Renal function is assessed using serial measurements of creatinine and cystatin C, before and after contrast exposure. By comparing renal outcomes, congestion status, and safety profiles, this study aims to determine whether a decongestion-focused approach provides superior renal protection compared with conventional hydration in high-risk acute heart failure patients.
Detailed description
Patients hospitalized with acute heart failure frequently require contrast-enhanced computed tomography or coronary imaging to identify precipitating etiologies and guide management. However, many of these patients have concomitant renal dysfunction, and exposure to iodinated contrast media places them at high risk for contrast-induced acute kidney injury (CI-AKI). Conventional prevention strategies rely on periprocedural intravenous isotonic saline hydration, which may be inappropriate or harmful in the setting of acute heart failure due to the risk of worsening congestion and pulmonary edema. Consequently, optimal renal protection strategies for this vulnerable population remain uncertain. The Kidney Protection Strategies Evaluation in Acute Heart Failure (K-PROSE) study is a prospective, randomized clinical study designed to compare two renal protection strategies in patients hospitalized with acute heart failure and moderate renal dysfunction who are scheduled to undergo contrast-enhanced computed tomography. Eligible patients are randomly assigned to receive either standard intravenous isotonic saline hydration or a furosemide-based decongestion strategy prior to and following contrast exposure. The study is designed to reflect real-world clinical practice while systematically evaluating renal and congestion-related outcomes. Renal function is assessed using serial measurements of serum creatinine and estimated glomerular filtration rate, along with emerging biomarkers of kidney injury, including cystatin C and neutrophil gelatinase-associated lipocalin (NGAL). These biomarkers are incorporated to enable early and sensitive detection of renal injury beyond conventional creatinine-based definitions. Urine chemistry parameters, including fractional excretion of sodium, are also collected to characterize renal physiology and treatment response. In parallel, markers of volume status and heart failure severity-including daily body weight, urine output, physical examination findings, chest radiography, and natriuretic peptide levels-are prospectively recorded to evaluate the effects of each strategy on congestion and hemodynamic stability. Safety assessments include monitoring for electrolyte abnormalities, hypotension, worsening heart failure, and other adverse events throughout the study period. By directly comparing a conventional hydration-based approach with a decongestion-focused strategy in a high-risk acute heart failure population, the K-PROSE study aims to clarify whether renal protection can be achieved without exacerbating congestion. The findings are expected to provide clinically relevant evidence to guide contrast-related decision-making and renal protection strategies in patients with acute heart failure and impaired kidney function.
Interventions
DRUGFurosemide
Intravenous furosemide administered to promote diuresis as part of a decongestion-based renal protection strategy.
Intravenous isotonic saline administered as standard hydration for the prevention of contrast-induced acute kidney injury.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 20 years or older * Emergency department visit/hospitalization for acute heart failure with clinical evidence of congestion * Planned contrast-enhanced computed tomography during the index hospitalization * Baseline renal dysfunction defined as an estimated glomerular filtration rate (eGFR) of 30-75 mL/min/1.73 m²
Exclusion criteria
* Requirement for vasopressor therapy * Requirement for renal replacement therapy (dialysis) * Known allergy or hypersensitivity to furosemide * Ongoing acute coronary syndrome * Pregnant or breastfeeding women, or women of childbearing potential without a negative pregnancy test * Hyperkalemia (serum potassium \>5.5 mmol/L) * Uncorrected volume depletion or hyponatremia (serum sodium \<130 mmol/L) * Any condition deemed by the investigator to make participation in the study inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of contrast-induced acute kidney injury | baseline and at 48 hours | Contrast-induced acute kidney injury is defined as an increase in serum creatinine or cystatin C of ≥0.3 mg/dL or ≥25% from baseline within 48 hours after contrast-enhanced computed tomography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum cystatin C level | Baseline and at 48 hours | Change in serum cystatin C from baseline to 48 hours after contrast-enhanced computed tomography. |
| Change in body weight | Baseline, up to 7 days | Change in body weight from baseline to day 7 |
| All-cause mortality | Baseline, day 90 | all-cause mortality |
| Length of stay | Baseline, day 90 | length of stay |
| ICU admission | Baseline, day 90 | ICU admission |
| Worsening heart failure | At day 90 | Worsening heart failure (hospitalization, emergency department visit, unscheduled clinic visit) |
| Change of other laboratory parameters | Baseline and at day 7 | Change in NT-proBNP from baseline to day 7 after contrast-enhanced computed tomography |
Countries
South Korea
Contacts
CONTACTJin Joo Park, MD, PhD
PRINCIPAL_INVESTIGATORJin Joo Park, MD, PhD
Seoul National University Bundang Hospital
Outcome results
None listed