Natriuresis-Guided Diuretic Therapy in Patients With Acute Heart Failure With Reduced Ejection Fraction and Chronic Kidney Disease
NCT ID: NCT06203236
Last Updated: 2024-01-12
Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2024-01-31
2025-11-30
Brief Summary
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Detailed Description
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Patients with both AHF and CKD often experience disrupted fluid dynamics, biochemically, it appears covertly as an abnormality in renal function and when progressive, is manifested by symptom exacerbation and worsening renal impairment during application of therapy to ameliorate such symptoms. The pathways leading to these distinct impairments involve not only hemodynamic deterioration but also neurohormonal, inflammatory, and intrinsic renal mechanisms that produce this syndrome .
Natriuresis-guided diuretic therapy, by focusing on the excretion of sodium in the urine. Natriuresis-guided diuretic therapy assesses sodium excretion in urine, offering a direct way to gauge diuretic effectiveness in managing fluid in heart failure (HF) patients. In HF, neurohormonal activation can cause resistance to loop diuretics, leading to persistent congestion. Urinary sodium (UNa) measurement, recommended by ESC guidelines, helps evaluate diuretic response. Early UNa assessment aligns with observational studies, but controlled trials are ongoing. Traditional metrics like weight loss have limitations. UNa assessment can assist diuretic therapy, but factors like fluid overload severity, timing of assessment, kidney disease, and diuretic type should be considered .
One of the primary advantages of natriuresis-guided therapy is its potential to tailor treatment strategies to individual patient responses. It recognizes that not all patients with AHF and CKD will respond to diuretics in the same way. Natriuretic response measured via the urinary sodium (UNa) concentration in a urine spot sample has gained popularity as a metric used for early assessment of diuretic response. In patients with chronic kidney disease admitted for AHF, assessment of intrinsic renal sodium avidity using a random UNa spot sample provides an opportunity to gain insights into decongestive and diuretic responses to IV diuretic drug administration .
The concept of natriuresis-guided therapy represents a departure from the conventional one-size-fits-all treatment model in acute heart failure (AHF) management. Instead, it aligns with the emerging paradigm of precision medicine, emphasizing that personalized therapeutic decisions should be based on individual patient attributes, notably renal function. This approach holds promise for optimizing diuretic therapy, mitigating the frequency of hospital readmissions, and enhancing the overall quality of life for individuals concurrently experiencing AHF and chronic kidney disease (CKD).
One significant challenge in implementing natriuresis-guided therapy is the need for frequent and accurate measurements of urinary sodium excretion. Urine collection and sodium analysis can be cumbersome and may require specialized equipment .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Natriuresis-guided group
Natriuresis-guided therapy group receiving diuretic therapy guided by natriuresis measurements.
Furosemide 20 MG
1. The median daily total dose of intravenous loop diuretic at the start of treatment will be 20 mg of furosemide.
2. Monitoring of urinary sodium excretion (natriuresis) and diuresis will begin 2 hours after treatment initiation.
diuretic therapy
diuretic therapy
Control group
Patients with matched age and sex as control group receiving diuretic therapy only.
Furosemide 20 MG
1. The median daily total dose of intravenous loop diuretic at the start of treatment will be 20 mg of furosemide.
2. Monitoring of urinary sodium excretion (natriuresis) and diuresis will begin 2 hours after treatment initiation.
diuretic therapy
diuretic therapy
Interventions
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Furosemide 20 MG
1. The median daily total dose of intravenous loop diuretic at the start of treatment will be 20 mg of furosemide.
2. Monitoring of urinary sodium excretion (natriuresis) and diuresis will begin 2 hours after treatment initiation.
diuretic therapy
diuretic therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with chronic kidney disease (CKD) stages 1-4.
* Patients aged 18 years or older.
* Patients accept to participate in the study.
Exclusion Criteria
* Patients with acute coronary syndrome.
* Patients with acute cardiogenic shock.
* Patients with dyspnea primarily due to non-cardiac cause (significant COPD).
* Patients with severe renal impairment requiring dialysis (GFR \< 15 mL/min/1.73 m²).
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Hala Hisham Mohammed Hasan
Principal investigator
Principal Investigators
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Salah Eldin Sayed Atta, Supervisor
Role: STUDY_CHAIR
Assiut University
Heba Mahmoud Abdel-Mohsen El-Naggar, Supervisor
Role: STUDY_DIRECTOR
Assiut University
Mohamed Abdullah Khalifah, Supervisor
Role: STUDY_DIRECTOR
South Valley University
Central Contacts
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References
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Testani JM, Hanberg JS, Cheng S, Rao V, Onyebeke C, Laur O, Kula A, Chen M, Wilson FP, Darlington A, Bellumkonda L, Jacoby D, Tang WH, Parikh CR. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Circ Heart Fail. 2016 Jan;9(1):e002370. doi: 10.1161/CIRCHEARTFAILURE.115.002370.
Deferrari G, Cipriani A, La Porta E. Renal dysfunction in cardiovascular diseases and its consequences. J Nephrol. 2021 Feb;34(1):137-153. doi: 10.1007/s40620-020-00842-w. Epub 2020 Sep 1.
Raina R, Nair N, Chakraborty R, Nemer L, Dasgupta R, Varian K. An Update on the Pathophysiology and Treatment of Cardiorenal Syndrome. Cardiol Res. 2020 Apr;11(2):76-88. doi: 10.14740/cr955. Epub 2020 Mar 10.
Brown JR, Uber PA, Mehra MR. The progressive cardiorenal syndrome in heart failure: mechanisms and therapeutic insights. Curr Treat Options Cardiovasc Med. 2008 Aug;10(4):342-8. doi: 10.1007/s11936-008-0054-5.
Oliva-Damaso N, Nunez J, Soler MJ. Spot Urinary Sodium as a Biomarker of Diuretic Response in Acute Heart Failure. J Am Heart Assoc. 2023 Sep 5;12(17):e030044. doi: 10.1161/JAHA.123.030044. Epub 2023 Aug 23. No abstract available.
Martens P, Chen HH, Verbrugge FH, Testani JT, Mullens W, Tang WHW. Assessing intrinsic renal sodium avidity in acute heart failure: implications in predicting and guiding decongestion. Eur J Heart Fail. 2022 Oct;24(10):1978-1987. doi: 10.1002/ejhf.2662. Epub 2022 Sep 6.
Meekers E, Mullens W. Spot Urinary Sodium Measurements: the Future Direction of the Treatment and Follow-up of Patients with Heart Failure. Curr Heart Fail Rep. 2023 Feb;20(1):88-100. doi: 10.1007/s11897-023-00591-4. Epub 2023 Feb 21.
Ter Maaten JM, Beldhuis IE, van der Meer P, Krikken JA, Coster JE, Nieuwland W, van Veldhuisen DJ, Voors AA, Damman K. Natriuresis-guided therapy in acute heart failure: rationale and design of the Pragmatic Urinary Sodium-based treatment algoritHm in Acute Heart Failure (PUSH-AHF) trial. Eur J Heart Fail. 2022 Feb;24(2):385-392. doi: 10.1002/ejhf.2385. Epub 2022 Jan 6.
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.
Other Identifiers
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Natriuresis-Guided Diuretics
Identifier Type: -
Identifier Source: org_study_id
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