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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Pro-Cardiaco Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Universidade Federal Fluminense
Hospital Universitário Antonio Pedro
Diagnósticos da América S.A.
Information provided by:
Pro-Cardiaco Hospital
ClinicalTrials.gov Identifier:
NCT01364636
First received: May 9, 2011
Last updated: June 6, 2011
Last verified: April 2011
  Purpose

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.


Condition
Cardiorenal Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) in Predicting Cardio-renal Syndrome in Acute Decompensated Heart Failure at Emergency - CYNDERELA-HF Study

Resource links provided by NLM:


Further study details as provided by Pro-Cardiaco Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

Urine plasma serum


Estimated Enrollment: 180
Study Start Date: February 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Heart Failure
Patients admitted to emergency room in Acute Heart Failure at Hospital PróCardíaco and Hospital Universitario Antonio Pedro

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364636

Contacts
Contact: Marcelo W Montera, PhD 552191780034 mmontera@uol.com.br
Contact: Monica DC Freire, MD 552191780034 monica.freire@dasa.com.br

Locations
Brazil
Hospital Universitário Antonio Pedro Active, not recruiting
Rio de Janeiro, RJ, Brazil, 22280-000
Hospital Universitário Antonio Pedro Recruiting
Rio de Janeiro, RJ, Brazil, 22280-000
Contact: Monica DC Freire, MD    552191780034    monica.freire@dasa.com.br   
Contact: Evandro T Mesquista, PhD    552199857631    etmesquita@gmail.com   
Principal Investigator: Marcelo W Montera, MD, PhD         
Sponsors and Collaborators
Pro-Cardiaco Hospital
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
  More Information

No publications provided

Responsible Party: Evandro Tinoco Mesquita, PhD, Coordinator of Post Graduation Courses of the Department of Cardiovascular Sciences, Fluminense Federal University, Medical Director Hospital PróCardíaco, Department of Cardiovascular Sciences - Fluminense Federal University, Hospital PróCardíaco
ClinicalTrials.gov Identifier: NCT01364636     History of Changes
Other Study ID Numbers: CYNDERELA-HF
Study First Received: May 9, 2011
Last Updated: June 6, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Pro-Cardiaco Hospital:
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:
Cardio-Renal Syndrome
Heart Failure
Syndrome
Cardiovascular Diseases
Disease
Heart Diseases
Kidney Diseases
Pathologic Processes
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014