Clinical Findings and Albuminuria as Predictors of Acute Kidney Injury in Patients With Acute Heart Failure

NCT ID: NCT06621862

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

assess the predictive value of clinical examination and proteinuria as early measures for acute kidney injury (AKI) in patient with acute heart failure and assessing their prognostic value as measures for mortality during hospital stay

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Heart failure (HF) is a chronic and progressive clinical syndrome induced by structural or functional cardiac abnormalities displaying either reduced (in HF with reduced ejection fraction (HFrEF)) or preserved (in HF with preserved ejection fraction (HFpEF)) left ventricular ejection fraction (LVEF) (1).

Current guidelines define the acute decompensated heart failure (ADHF) syndrome as the presence of new or worsening signs and symptoms of HF that often lead to hospitalization or an emergency department visit for intensification of therapies (2-4). Due to population growth and ageing, the total number of HF patients continues to rise. It is estimated that 64.3 million people live with HF worldwide. In developed countries, the prevalence of known HF is generally estimated at 1-2% of the general adult population.(3, 5)

Acute kidney injury (AKI) is a frequently occurring complication of critical illness, with severe impact on morbidity and mortality. Many studies focus on advanced measures, such as biomarkers or imaging for predicting AKI. These techniques are frequently time-consuming, costly, and are not available on a global scale. In contrast, variables obtained by clinical examination are readily available without limitations by set- tings or costs. Clinical examination signs and symptoms may reflect the underlying disease state and could therefore potentially be used to identify patients at risk for AKI . In addition, a few studies have specifically focused on the role of albuminuria in predicting adverse outcomes in heart failure patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Acute Kidney Injury Albuminuria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients of 18 years and older who will be admitted to the ICU with acute heart failure (acute heart failure is defined according ESC guidelines 2021 which include Heart Failure with Reduced Ejection Fraction (HFrEF) EF \<40% . Mid-Range Ejection Fraction (HFmrEF)(41 -46 %) , Preserved Ejection Fraction (HFpEF) EF ≥ 50%.

Exclusion Criteria

* patients under the age of 18.

Patients with known chronic kidney disease (CKD) before ICU admission (CKD is defined as the presence of kidney damage or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 mt2, persisting for 3 months or more, and or albuminuria more than 3.5 mg/mmol (12)

severe UTI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role collaborator

Hagar Mahmoud Hammad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hagar Mahmoud Hammad

Hagar Mahmoud Hammad

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ashraf Anwar Elshazly, Prof

Role: CONTACT

0201062879221

Ahmed Samir, Dr

Role: CONTACT

0201150730888

References

Explore related publications, articles, or registry entries linked to this study.

Levin A, Ahmed SB, Carrero JJ, Foster B, Francis A, Hall RK, Herrington WG, Hill G, Inker LA, Kazancioglu R, Lamb E, Lin P, Madero M, McIntyre N, Morrow K, Roberts G, Sabanayagam D, Schaeffner E, Shlipak M, Shroff R, Tangri N, Thanachayanont T, Ulasi I, Wong G, Yang CW, Zhang L, Robinson KA, Wilson L, Wilson RF, Kasiske BL, Cheung M, Earley A, Stevens PE. Executive summary of the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease: known knowns and known unknowns. Kidney Int. 2024 Apr;105(4):684-701. doi: 10.1016/j.kint.2023.10.016.

Reference Type RESULT
PMID: 38519239 (View on PubMed)

Masson S, Latini R, Milani V, Moretti L, Rossi MG, Carbonieri E, Frisinghelli A, Minneci C, Valisi M, Maggioni AP, Marchioli R, Tognoni G, Tavazzi L; GISSI-HF Investigators. Prevalence and prognostic value of elevated urinary albumin excretion in patients with chronic heart failure: data from the GISSI-Heart Failure trial. Circ Heart Fail. 2010 Jan;3(1):65-72. doi: 10.1161/CIRCHEARTFAILURE.109.881805. Epub 2009 Oct 22.

Reference Type RESULT
PMID: 19850697 (View on PubMed)

Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5. No abstract available.

Reference Type RESULT
PMID: 23741057 (View on PubMed)

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.

Reference Type RESULT
PMID: 34447992 (View on PubMed)

Hollenberg SM, Warner Stevenson L, Ahmad T, Amin VJ, Bozkurt B, Butler J, Davis LL, Drazner MH, Kirkpatrick JN, Peterson PN, Reed BN, Roy CL, Storrow AB. 2019 ACC Expert Consensus Decision Pathway on Risk Assessment, Management, and Clinical Trajectory of Patients Hospitalized With Heart Failure: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2019 Oct 15;74(15):1966-2011. doi: 10.1016/j.jacc.2019.08.001. Epub 2019 Sep 13. No abstract available.

Reference Type RESULT
PMID: 31526538 (View on PubMed)

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.

Reference Type RESULT
PMID: 27206819 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AKI and heart failure

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.