Contrast-Induced Acute Kidney Injury Prevention in Acute Heart Failure

NCT07550790 | Recruiting DMC

• 1 other identifier: B-2201-735-004
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure Acute; Renal Dysfunction

Keywords

contrast-induced acute kidney injury; decongestion; hydration

Outcome Measures

Primary Outcomes (1)

• Incidence of contrast-induced acute kidney injury

  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 Outcomes (8)

• Change in serum cystatin C level

  Baseline and at 48 hours

• Change in body weight

  Baseline, up to 7 days

• All-cause mortality

  Baseline, day 90

• Length of stay

  Baseline, day 90

• ICU admission

  Baseline, day 90

Study Arms (2)

Standard Intravenous Saline Hydration

ACTIVE COMPARATOR

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

Furosemide-Based Decongestion Strategy

EXPERIMENTAL

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

Interventions

Furosemide DRUG

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

Furosemide-Based Decongestion Strategy

0.9 % Normal Saline DRUG

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

Standard Intravenous Saline Hydration

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

RECRUITING

Related Publications (12)

• Park J, Mebazaa A, Park JJ, Rhee TM, Park HA, Lee GY, Choi JO, Jeon ES, Lee SE, Cho HJ, Lee HY, Oh BH, Choi DJ; Korean Acute Heart Failure (KorAHF) Investigators. Incidence, Risk Factors and Prognosis of Contrast-Induced Acute Kidney Injury in Acute Heart Failure Patients Undergoing Coronary Angiography. Int J Heart Fail. 2019 Oct 24;1(1):72-85. doi: 10.36628/ijhf.2019.0006. eCollection 2019 Oct.

  PMID: 36262741 BACKGROUND

• Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.

  PMID: 24856027 BACKGROUND

• Solomon RJ, Mehran R, Natarajan MK, Doucet S, Katholi RE, Staniloae CS, Sharma SK, Labinaz M, Gelormini JL, Barrett BJ. Contrast-induced nephropathy and long-term adverse events: cause and effect? Clin J Am Soc Nephrol. 2009 Jul;4(7):1162-9. doi: 10.2215/CJN.00550109. Epub 2009 Jun 25.

  PMID: 19556381 BACKGROUND

• Brar SS, Shen AY, Jorgensen MB, Kotlewski A, Aharonian VJ, Desai N, Ree M, Shah AI, Burchette RJ. Sodium bicarbonate vs sodium chloride for the prevention of contrast medium-induced nephropathy in patients undergoing coronary angiography: a randomized trial. JAMA. 2008 Sep 3;300(9):1038-46. doi: 10.1001/jama.300.9.1038.

  PMID: 18768415 BACKGROUND

• Trivedi HS, Moore H, Nasr S, Aggarwal K, Agrawal A, Goel P, Hewett J. A randomized prospective trial to assess the role of saline hydration on the development of contrast nephrotoxicity. Nephron Clin Pract. 2003 Jan;93(1):C29-34. doi: 10.1159/000066641.

  PMID: 12411756 BACKGROUND

• Briguori C, Airoldi F, D'Andrea D, Bonizzoni E, Morici N, Focaccio A, Michev I, Montorfano M, Carlino M, Cosgrave J, Ricciardelli B, Colombo A. Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies. Circulation. 2007 Mar 13;115(10):1211-7. doi: 10.1161/CIRCULATIONAHA.106.687152. Epub 2007 Feb 19.

  PMID: 17309916 BACKGROUND

• Testani JM, Ter Maaten JM. Decongestion in Acute Heart Failure: Does the End Justify the Means? JACC Heart Fail. 2016 Jul;4(7):589-590. doi: 10.1016/j.jchf.2016.03.024. No abstract available.

  PMID: 27364968 BACKGROUND

• Ronco C, Cicoira M, McCullough PA. Cardiorenal syndrome type 1: pathophysiological crosstalk leading to combined heart and kidney dysfunction in the setting of acutely decompensated heart failure. J Am Coll Cardiol. 2012 Sep 18;60(12):1031-42. doi: 10.1016/j.jacc.2012.01.077. Epub 2012 Jul 25.

  PMID: 22840531 BACKGROUND

• Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.

  PMID: 15464318 BACKGROUND

• Olin JW, Allie DE, Belkin M, Bonow RO, Casey DE Jr, Creager MA, Gerber TC, Hirsch AT, Jaff MR, Kaufman JA, Lewis CA, Martin ET, Martin LG, Sheehan P, Stewart KJ, Treat-Jacobson D, White CJ, Zheng ZJ, Masoudi FA. ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS 2010 performance measures for adults with peripheral artery disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on performance measures, the American College of Radiology, the Society for Cardiac Angiography and Interventions, the Society for Interventional Radiology, the Society for Vascular Medicine, the Society for Vascular Nursing, and the Society for Vascular Surgery (Writing Committee to Develop Clinical Performance Measures for Peripheral Artery Disease). Circulation. 2010 Dec 14;122(24):2583-618. doi: 10.1161/CIR.0b013e3182031a3c. Epub 2010 Nov 29. No abstract available.

  PMID: 21126978 BACKGROUND

• Chalikias G, Drosos I, Tziakas DN. Prevention of Contrast-Induced Acute Kidney Injury: an Update. Cardiovasc Drugs Ther. 2016 Oct;30(5):515-524. doi: 10.1007/s10557-016-6683-0.

  PMID: 27541275 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Furosemide; Saline Solution

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jin Joo Park, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Joo Park, MD, PhD

CONTACT

+82-031-787-8800; jinjooparkmd@snubh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): January 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

KR (1)