Accuracy of Urinary NGAL in Predicting CardioRenal Syndrome in Acute Heart Failure at Emergency - CYNDERELA-HF Study

Study Overview
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Brief Summary
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Rationale: Heart Failure (HF) elevated prevalence in Brasil and the world; 20-30% AHF patients develop CardioRenal Syndrome (CRS) type 1; Worsening Renal Failure (WRF) is a prognostic marker of mortality in Acute HF;NGAL is a novel biomarker of Acute Kidney Injury released in 2 hours, and addressed in several different clinical scenarios(contrast injury, cardiopulmonary bypass, critical illness. Hypothesis: Admission NGAL predicts CRS in AHF patients admitted to the Emergency Room (ER). Primary goal: To evaluate the diagnostic accuracy and the best cutoff value of urinary NGAL to predict the development of CRS type 1 in patients admitted to the Emergency Room. Secondary goals: 1- To evaluate the prognostic impact of NGAL on in-hospital adverse outcomes (length of hospitalization, death, institution of renal replacement therapy, use of vasoactive drugs, mechanical ventilation).2- Evaluate the prognostic impact of NGAL in adverse outcomes in 30 days, 60 days and 6 months (death, rehospitalization, institution of renal replacement therapy).3- Identify clinical and hemodynamic characteristics of Acute HF that can influence the evolutionary behavior of NGAL levels in 48 hours.4- Identify the association of drugs commonly used for HF management, which might influence the evolutionary behavior of NGAL levels in 48 hours.5-Assess the impact of NGAL results in clinical decision making. Methods: Observational, prospective, blinded study. Population: Acute HF patients admitted to the ER of Hospital Pró Cardiaco and Hospital Antonio Pedro - Universidade Federal Fluminense. Statistics: Convenience Sample size (n=180); determination of best cut-off: ROC analysis; Predictive performance of the cut-off: sensibility, specificity, likelihood ratio, predictive value, accuracy; Identification of variables to predict CRS: logistic regression and square-Qui test; Correlations analysis of normally distributed variables: Pearson's linear correlation test; Mean values for normally distributed variables: Mann-Wittney test; Significance on p<0,05; Intra-assay variation analysis. Study chronogram: Recruitment: 12 months; Results analysis and conclusions: 60 days; Manuscript preparation for paper submission: 30 days.

Detailed Description
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Rationale: Heart Failure (HF) elevated prevalence in Brasil and the world; 20-30% AHF patients develop CardioRenal Syndrome (CRS) type 1; Worsening Renal Failure (WRF) is a prognostic marker of mortality in Acute HF; available biomarker shows irreversible damage, late in CRS evolution.(creatinine);NGAL is a novel biomarker of Acute Kidney Injury released in 2 hours, and addressed in several different clinical scenarios(contrast injury, cardiopulmonary bypass, critical illness...); Acute HF patient's risk stratification will allow appropriate resource allocation and establishment of criteria for hospital admission and discharge. Hypothesis: Admission NGAL predicts CRS in AHF patients admitted to the Emergency Room (ER). Primary goal: To evaluate the diagnostic accuracy and the best cutoff value of urinary NGAL to predict the development of CRS type 1 in patients admitted to the Emergency Room. Secondary goals: 1- To evaluate the prognostic impact of NGAL on in-hospital adverse outcomes (length of hospitalization, death, institution of renal replacement therapy, use of vasoactive drugs, mechanical ventilation).2- Evaluate the prognostic impact of NGAL in adverse outcomes in 30 days, 60 days and 6 months (death, rehospitalization, institution of renal replacement therapy).3- Identify clinical and hemodynamic characteristics of Acute HF that can influence the evolutionary behavior of NGAL levels in 48 hours.4- Identify the association of drugs commonly used for HF management, which might influence the evolutionary behavior of NGAL levels in 48 hours.5-Assess the impact of NGAL results in clinical decision making. Methods: Observational, prospective, blinded study. Population: Acute HF patients admitted to the ER of Hospital Pró Cardiaco and Hospital Antonio Pedro - Universidade Federal Fluminense. Statistics: Convenience Sample size (n=180); determination of best cut-off: ROC analysis; Predictive performance of the cut-off: sensibility, specificity, likelihood ratio, predictive value, accuracy; Identification of variables to predict CRS: logistic regression and square-Qui test; Correlations analysis of normally distributed variables: Pearson's linear correlation test; Mean values for normally distributed variables: Mann-Wittney test; Significance on p<0,05; Intra-assay variation analysis. Study chronogram: Recruitment: 12 months; Results analysis and conclusions: 60 days; Manuscript preparation for paper submission: 30 days.

Official Title
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Accuracy of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) in Predicting Cardio-renal Syndrome in Acute Decompensated Heart Failure at Emergency - CYNDERELA-HF Study

Conditions
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Cardiorenal Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute heart failure according to the Framingham's criteria informed consent signed Exclusion Criteria: Acute coronary syndrome cardiogenic shock terminal renal disease transplanted patients known nephrotoxicity exposure urinary tract infection sepsis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Heart Failure<br>Patients admitted to emergency room in Acute Heart Failure at Hospital PróCardíaco and Hospital Universitario Antonio Pedro | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CardioRenal Syndrome type 1 development | CardioRenal Syndrome type 1 development defined by the elevation of serum creatinine of 0,3mg/dL and/or of 50% of baseline values | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospitalization | number of days of the study entry hospitalization | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 
| in-hospital death | Death within the study entry hospitalization period | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 
| institution of renal replacement therapy | need for any kind of dyalisis procedure. | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 
| need to use of vasoactive drugs | if the patient was submitted to use of vasoactive drugs as dopamine, dobutamine, noradrenaline, milrinone, and other vasoactive drugs | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 
| mechanical ventilation | if the patient was submitted to mechanical ventilation during the hospitalization period | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 
| death | death after study entry hospitalization discharge | patients will be followed up to 360 days after hospital discharge | 
| rehospitalization | need to be admitted to any hospital after study entry hospitalization discharge | patients will be followed up to 360 days after hospital discharge | 
| institution of renal replacement therapy | need to be submitted to any dyalisis procedure after study entry hospitalization discharge | patients will be followed up to 360 days after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1-Heart Failure, 2-Acute Heart Failure, 3-Acute Decompensated Heart Failure, 4-Worsening Renal Function, 5-Acute Kidney Injury, 6-Cardiorenal Syndrome