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NCT Number: NCT07550790

Contrast-Induced Acute Kidney Injury Prevention in Acute Heart Failure

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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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location status: Recruiting

Location contact

Minjae Yoon, MD

CONTACT

[email protected]

+82-31-787-7000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of contrast-associated 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

Secondary outcomes

  1. Acute kidney injury

    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

  2. serum creatinine and eGFR

    Time frame: baseline through day 7

    Change in serum creatinine and eGFR from baseline through day 7

  3. 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.

  4. Change of NGAL

    Time frame: Baseline and at 24 and 48 hours

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

  5. Change of NT-proBNP

    Time frame: Baseline and at day 7

    Change in NT-proBNP from baseline to day 7 after contrast-enhanced computed tomography

  6. Change in body weight

    Time frame: Baseline, up to 7 days

    Change in body weight from baseline to day 7

  7. All-cause mortality

    Time frame: Baseline, day 90

    all-cause mortality

  8. Length of stay

    Time frame: Baseline, day 90

    length of stay

  9. ICU admission

    Time frame: Baseline, day 90

    ICU admission

  10. Worsening heart failure

    Time frame: At day 90

    Worsening heart failure (hospitalization, emergency department visit, unscheduled clinic visit)

  11. Renal replacement therapy

    Time frame: day 90

    Renal replacement therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Joo Park, MD, PhD

CONTACT

[email protected]

+82-031-787-8800

Sponsors and collaborators

Lead sponsor

Jin Joo Park

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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