Contrast-Induced Acute Kidney Injury Prevention in Acute Heart Failure

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Furosemide
  Intravenous furosemide administered to promote diuresis as part of a decongestion-based renal protection strategy.
• Препарат 0.9 % Normal Saline
  Intravenous isotonic saline administered as standard hydration for the prevention of contrast-induced acute kidney injury.

Первичные конечные точки

• Incidence of contrast-associated acute kidney injury [Срок оценки: at 48 hours]

Вторичные конечные точки (11)

• Acute kidney injury [Срок оценки: 48 hours]
• serum creatinine and eGFR [Срок оценки: baseline through day 7]
• Change in serum cystatin C level [Срок оценки: Baseline and at 48 hours]
• Change of NGAL [Срок оценки: Baseline and at 24 and 48 hours]
• Change of NT-proBNP [Срок оценки: Baseline and at day 7]
• Change in body weight [Срок оценки: Baseline, up to 7 days]
• All-cause mortality [Срок оценки: Baseline, day 90]
• Length of stay [Срок оценки: Baseline, day 90]
• ICU admission [Срок оценки: Baseline, day 90]
• Worsening heart failure [Срок оценки: At day 90]
• Renal replacement therapy [Срок оценки: day 90]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

South Korea · 1 центр

• Seoul National University Bundang Hospital — Seongnam-si

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07550790 · B-2201-735-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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