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Contrast-Induced Acute Kidney Injury Prevention in Acute Heart Failure

ConditionsHeart Failure AcuteRenal Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorJin Joo Park

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Requirement for vasopressor therapy

Requirement for renal replacement therapy (dialysis)

Known allergy or hypersensitivity to furosemide

Ongoing acute coronary syndrome

Trial design

Design model

Parallel

Treatments tested in this trial

  • Furosemide

    Drug

    Intravenous furosemide administered to promote diuresis as part of a decongestion-based renal protection strategy.

  • 0.9 % Normal Saline

    Drug

    Intravenous isotonic saline administered as standard hydration for the prevention of contrast-induced acute kidney injury.

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Standard Intravenous Saline HydrationActive comparator 1 intervention
Group B: Furosemide-Based Decongestion StrategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of contrast-associated acute kidney injury

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
at 48 hours

Secondary outcomes

1

Acute kidney injury

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
48 hours
2

serum creatinine and eGFR

Change in serum creatinine and eGFR from baseline through day 7

Time frame
baseline through day 7
3

Change in serum cystatin C level

Change in serum cystatin C from baseline to 48 hours after contrast-enhanced computed tomography.

Time frame
Baseline and at 48 hours
4

Change of NGAL

Change in NGAL from baseline to 24 and 48 hours after contrast-enhanced computed tomography

Time frame
Baseline and at 24 and 48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jin Joo Park

Lead sponsor

Seoul National University Bundang Hospital

Sponsor institution

Source ClinicalTrials.gov
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