Protocolised Natriuresis-Guided Decongestion at Different Diuretic Intensities in Acute Heart Failure

Summary

The goal of this clinical trial is to learn how different doses of a water-removing medicine (diuretic) work in adults admitted to hospital with acute heart failure. It will also assess the safety of these treatment approaches. The main questions this study aims to answer are: Does starting with a higher or lower dose of diuretic affect how much sodium and urine the body removes during the first 24 hours? Are there differences in side effects or short-term health outcomes between the treatment approaches? Researchers will compare two treatment approaches that use urine sodium and urine output to guide diuretic treatment with standard care. Participants will receive intravenous diuretic treatment and have their urine sodium, urine output, symptoms, blood tests, and clinical outcomes assessed.

Timeline

Start

2026-01-01

Primary completion

2026-07-01

Completion

2026-07-31

Publications

• Background Al-Shammari AS, Hamzah KA, Masanabadi M, Asif M, Budhiraja M, Shafi N, Hamed BM, Kurmasha YH, Shweliya MA, Sattar Y. Urinary sodium-guided diuretic therapy in acute decompensated heart failure: A grade assessed systematic review and meta-analysis with trial sequential analysis. Curr Probl Cardiol. 2026 May;51(5):103272. doi: 10.1016/j.cpcardiol.2026.103272. Epub 2026 Jan 20.
• Background Meekers E, Dauw J, Ter Maaten JM, Martens P, Nijst P, Verbrugge FH, Van Es M, Erzeel J, Damman K, Trullas JC, Dupont M, Mullens W. Urinary sodium analysis: The key to effective diuretic titration? European Journal of Heart Failure expert consensus document. Eur J Heart Fail. 2025 Jun;27(6):940-949. doi: 10.1002/ejhf.3632. Epub 2025 Feb 27.
• Background ter Maaten JM, Valente MA, Damman K, Hillege HL, Navis G, Voors AA. Diuretic response in acute heart failure-pathophysiology, evaluation, and therapy. Nat Rev Cardiol. 2015 Mar;12(3):184-92. doi: 10.1038/nrcardio.2014.215. Epub 2015 Jan 6.
• Background Wan Ahmad WA, Abdul Ghapar AK, Zainal Abidin HA, Karthikesan D, Ross NT, S K Abdul Kader MA, Loch A, Mahendran K, Ramli AW, Ong TK, Mohd Amin NH, Lee CY, Che Hassan HH, Zainal Abidin SK, Liew HB, Ho WS, Mohd Ghazi A. Characteristics of patients admitted with heart failure: Insights from the first Malaysian Heart Failure Registry. ESC Heart Fail. 2024 Apr;11(2):727-736. doi: 10.1002/ehf2.14608. Epub 2023 Dec 22.
• Background Damman K, Ter Maaten JM, Coster JE, Krikken JA, van Deursen VM, Krijnen HK, Hofman M, Nieuwland W, van Veldhuisen DJ, Voors AA, van der Meer P. Clinical importance of urinary sodium excretion in acute heart failure. Eur J Heart Fail. 2020 Aug;22(8):1438-1447. doi: 10.1002/ejhf.1753. Epub 2020 Feb 22.
• Background McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
• Background Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
• Background Felker GM, Ellison DH, Mullens W, Cox ZL, Testani JM. Diuretic Therapy for Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 17;75(10):1178-1195. doi: 10.1016/j.jacc.2019.12.059.
• Background Mullens W, Damman K, Harjola VP, Mebazaa A, Brunner-La Rocca HP, Martens P, Testani JM, Tang WHW, Orso F, Rossignol P, Metra M, Filippatos G, Seferovic PM, Ruschitzka F, Coats AJ. The use of diuretics in heart failure with congestion - a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019 Feb;21(2):137-155. doi: 10.1002/ejhf.1369. Epub 2019 Jan 1.
• Background Dauw J, Charaya K, Lelonek M, Zegri-Reiriz I, Nasr S, Paredes-Paucar CP, Borbely A, Erdal F, Benkouar R, Cobo-Marcos M, Barge-Caballero G, George V, Zara C, Ross NT, Barker D, Lekhakul A, Frea S, Ghazi AM, Knappe D, Doghmi N, Klincheva M, Fialho I, Bovolo V, Findeisen H, Alhaddad IA, Galluzzo A, de la Espriella R, Tabbalat R, Miro O, Singh JS, Nijst P, Dupont M, Martens P, Mullens W. Protocolized Natriuresis-Guided Decongestion Improves Diuretic Response: The Multicenter ENACT-HF Study. Circ Heart Fail. 2024 Jan;17(1):e011105. doi: 10.1161/CIRCHEARTFAILURE.123.011105. Epub 2024 Jan 5.
• Background Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419.
• Background Ter Maaten JM, Beldhuis IE, van der Meer P, Krikken JA, Postmus D, Coster JE, Nieuwland W, van Veldhuisen DJ, Voors AA, Damman K. Natriuresis-guided diuretic therapy in acute heart failure: a pragmatic randomized trial. Nat Med. 2023 Oct;29(10):2625-2632. doi: 10.1038/s41591-023-02532-z. Epub 2023 Aug 28.

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Indications