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

Accuracy of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) in Predicting Cardio-renal Syndrome in Acute Decompensated 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.

Study Overview

• Status: Terminated
• Conditions: Cardiorenal Syndrome

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22280-000
      • Hospital Universitario Antonio Pedro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the Emergency rooms of Hospital PróCardíaco and Hospital Universitário Antonio Pedro, presenting with acute heart failure according to the Framingham's criteria. The subjects must sign the informed consent term.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute Heart Failure; Patients admitted to emergency room in Acute Heart Failure at Hospital PróCardíaco and Hospital Universitario Antonio Pedro

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pro-Cardiaco Hospital
• Collaborators: Universidade Federal Fluminense; Hospital Universitário Antonio Pedro; Diagnósticos da América S.A.
• Investigators: Principal Investigator: Evandro T Mesquita, PhD, Fluminense Federal University - Cardiovascular Sciences Department, coordinator of post graduation courses; Hospital PróCardíaco - Medical Director

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 2, 2011

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: 1-Heart Failure; 2-Acute Heart Failure; 3-Acute Decompensated Heart Failure; 4-Worsening Renal Function; 5-Acute Kidney Injury; 6-Cardiorenal Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Disease; Renal Insufficiency; Heart Failure; Syndrome; Emergencies; Cardio-Renal Syndrome
• Other Study ID Numbers: CYNDERELA-HF