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

• CardioRenal Syndrome type 1 development [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: Yes ]
  CardioRenal Syndrome type 1 development defined by the elevation of serum creatinine of 0,3mg/dL and/or of 50% of baseline values
  
  

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

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.