Contrast-Induced Acute Kidney Injury Prevention in Acute Heart Failure (K-PROSE)

April 19, 2026 updated by: Seoul National University Bundang Hospital

Contrast-Induced Acute Kidney Injury in Acute Heart Failure With Renal Dysfunction: The Kidney Protection Strategies Evaluation in Acute Heart Failure (K-PROSE)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Intravenous Saline Hydration
Participants receive standard intravenous hydration with 0.9% normal saline (1ml/kg) before and after contrast-enhanced computed tomography as a conventional strategy for the prevention of contrast-induced acute kidney injury.
Drug: 0.9 % Normal Saline
Intravenous isotonic saline administered as standard hydration for the prevention of contrast-induced acute kidney injury.
Experimental: Furosemide-Based Decongestion Strategy
Participants receive intravenous furosemide to achieve sufficient diuresis (target ≥1,000 mL) as a decongestion-based strategy for renal protection before contrast-enhanced computed tomography.
Drug: Furosemide
Intravenous furosemide administered to promote diuresis as part of a decongestion-based renal protection strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of contrast-induced acute kidney injury
Time Frame: 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.
baseline and at 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum cystatin C level
Time Frame: Baseline and at 48 hours
Change in serum cystatin C from baseline to 48 hours after contrast-enhanced computed tomography.
Baseline and at 48 hours
Change in body weight
Time Frame: Baseline, up to 7 days
Change in body weight from baseline to day 7
Baseline, up to 7 days
All-cause mortality
Time Frame: Baseline, day 90
all-cause mortality
Baseline, day 90
Length of stay
Time Frame: Baseline, day 90
length of stay
Baseline, day 90
ICU admission
Time Frame: Baseline, day 90
ICU admission
Baseline, day 90
Worsening heart failure
Time Frame: At day 90
Worsening heart failure (hospitalization, emergency department visit, unscheduled clinic visit)
At day 90
Change of other laboratory parameters
Time Frame: Baseline and at day 7
Change in NT-proBNP from baseline to day 7 after contrast-enhanced computed tomography
Baseline and at day 7
Change of other laboratory parameters
Time Frame: Baseline and at 48 hours
Change in NGAL from baseline to 48 hours after contrast-enhanced computed tomography
Baseline and at 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Jin Joo Park, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 30, 2029

Study Completion (Estimated)

January 30, 2029

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

April 19, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2201-735-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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