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