Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Location status: Recruiting
NCT Number: NCT07550790
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.
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All sexes
Interventional
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Seongnam-si, Gyeonggi-do, 13620, South Korea
Location status: Recruiting
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-associated acute kidney injury (CA-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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: at 48 hours
Incidence of contrast-associated acute kidney injury, defined as an increase in serum creatinine of ≥0.3 mg/dL from baseline or to ≥1.5 times the baseline value within 48 hours after contrast exposure
Time frame: 48 hours
An increase in serum creatinine of ≥0.5 mg/dL from baseline or to ≥1.25 times the baseline value within 48 hours after contrast exposure
Time frame: baseline through day 7
Change in serum creatinine and eGFR from baseline through day 7
Time frame: Baseline and at 48 hours
Change in serum cystatin C from baseline to 48 hours after contrast-enhanced computed tomography.
Time frame: Baseline and at 24 and 48 hours
Change in NGAL from baseline to 24 and 48 hours after contrast-enhanced computed tomography
Time frame: Baseline and at day 7
Change in NT-proBNP from baseline to day 7 after contrast-enhanced computed tomography
Time frame: Baseline, up to 7 days
Change in body weight from baseline to day 7
Time frame: Baseline, day 90
all-cause mortality
Time frame: Baseline, day 90
length of stay
Time frame: Baseline, day 90
ICU admission
Time frame: At day 90
Worsening heart failure (hospitalization, emergency department visit, unscheduled clinic visit)
Time frame: day 90
Renal replacement therapy
Contact information is provided by the study sponsor or research team.
Jin Joo Park
Other
Contrast-Induced Acute Kidney Injury in Acute Heart Failure With Renal Dysfunction: The Kidney Protection Strategies Evaluation in Acute Heart Failure (K-PROSE)
Acronym: K-PROSE
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