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

NCT01364636 | Terminated DMC

• 1 other identifier: CYNDERELA-HF
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiorenal Syndrome

Keywords

1-Heart Failure; 2-Acute Heart Failure; 3-Acute Decompensated Heart Failure; 4-Worsening Renal Function; 5-Acute Kidney Injury; 6-Cardiorenal Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• length of hospitalization

  participants will be followed for the duration of hospital stay, an expected average of 5 weeks

• in-hospital death

  participants will be followed for the duration of hospital stay, an expected average of 5 weeks

• institution of renal replacement therapy

  participants will be followed for the duration of hospital stay, an expected average of 5 weeks

• need to use of vasoactive drugs

  participants will be followed for the duration of hospital stay, an expected average of 5 weeks

• mechanical ventilation

  participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Study Arms (1)

Acute Heart Failure

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• acute heart failure according to the Framingham's criteria
• informed consent signed

You may not qualify if:

• Acute coronary syndrome
• cardiogenic shock
• terminal renal disease
• transplanted patients
• known nephrotoxicity exposure
• urinary tract infection
• sepsis

Sponsors & Collaborators

• Pro-Cardiaco Hospital: lead
• Universidade Federal Fluminense: collaborator
• Hospital Universitário Antonio Pedro: collaborator
• Diagnósticos da América S.A.: collaborator

Study Sites (1)

Hospital Universitário Antonio Pedro

Rio de Janeiro, Rio de Janeiro, 22280-000, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine plasma serum

MeSH Terms

Conditions

Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Evandro T Mesquita, PhD

  Fluminense Federal University - Cardiovascular Sciences Department, coordinator of post graduation courses; Hospital PróCardíaco - Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: June 2, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 21, 2018

Record last verified: 2011-04

Locations

BR (1)