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Heart Failure AcuteK-PROSENCT07550790

Contrast-Induced Acute Kidney Injury Prevention in Acute Heart Failure

A study testing Furosemide and 0.9 % Normal Saline in people with Heart Failure Acute and Renal Dysfunction, run by Jin Joo Park at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Heart Failure Acute, Renal Dysfunction
What is being tested?
Furosemide and 0.9 % Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteSouth Korea
Study dates
1 Jul 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jin Joo Park, MD, PhD contact

+82-031-787-8800

jinjooparkmd@snubh.org

South Korea1 site, 1 recruiting
  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Minjae Yoon, MD, +82-31-787-7000, minjae1677@snubh.org

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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-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.

Being tested
Furosemide, 0.9 % Normal Saline
Keywords
contrast-induced acute kidney injury, decongestion, hydration
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FurosemideDrug

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

  • 0.9 % Normal SalineDrug

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

Study groups in NCT07550790
Study groupRoleWhat they receive
Standard Intravenous Saline HydrationActive comparatorParticipants 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.
Receives: Drug: 0.9 % Normal Saline
Furosemide-Based Decongestion StrategyExperimentalParticipants receive intravenous furosemide to achieve sufficient diuresis (target ≥1,000 mL) as a decongestion-based strategy for renal protection before contrast-enhanced computed tomography.
Receives: Drug: Furosemide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at 48 hours

Secondary outcomes (11)
  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

    Measured: 48 hours

  2. serum creatinine and eGFR

    Change in serum creatinine and eGFR from baseline through day 7

    Measured: 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.

    Measured: Baseline and at 48 hours

  4. Change of NGAL

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

    Measured: Baseline and at 24 and 48 hours

  5. Change of NT-proBNP

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

    Measured: Baseline and at day 7

  6. Change in body weight

    Change in body weight from baseline to day 7

    Measured: Baseline, up to 7 days

  7. All-cause mortality

    all-cause mortality

    Measured: Baseline, day 90

  8. Length of stay

    length of stay

    Measured: Baseline, day 90

  9. ICU admission

    ICU admission

    Measured: Baseline, day 90

  10. Worsening heart failure

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

    Measured: At day 90

  11. Renal replacement therapy

    Renal replacement therapy

    Measured: day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07550790
Sponsor's protocol ID
B-2201-735-004
Acronym
K-PROSE
Status last verified
Jul 2026
First submitted
19 Feb 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36262741
  • 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.

    PubMed 24856027
  • 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.

    PubMed 19556381
  • 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.

    PubMed 18768415
  • 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.

    PubMed 12411756
  • 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.

    PubMed 17309916
  • 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.

    PubMed 27364968
  • 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.

    PubMed 22840531
  • 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.

    PubMed 15464318
  • 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.

    PubMed 21126978
  • 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.

    PubMed 27541275
  • 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.

    PubMed 27206819

Questions about this trial

What is this clinical trial studying?

A study testing Furosemide and 0.9 % Normal Saline in people with Heart Failure Acute and Renal Dysfunction, run by Jin Joo Park at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin Joo Park, MD, PhD (+82-031-787-8800, jinjooparkmd@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of contrast-associated acute kidney injury (time frame: at 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07550790, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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