Cardiorenal SyndromeCYNDERELA-HFNCT01364636
Accuracy of Urinary NGAL in Predicting CardioRenal Syndrome in Acute Heart Failure at Emergency - CYNDERELA-HF Study
An observational study of Cardiorenal Syndrome, run by Pro-Cardiaco Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiorenal Syndrome
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- acute heart failure according to the Framingham's criteria
- informed consent signed
Who cannot join
- Acute coronary syndrome
- cardiogenic shock
- terminal renal disease
- transplanted patients
- known nephrotoxicity exposure
- urinary tract infection
- sepsis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Antonio Pedro
Rio de Janeiro, Rio de Janeiro, 22280-000
About this study
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
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).
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Heart Failure | Patients admitted to emergency room in Acute Heart Failure at Hospital PróCardíaco and Hospital Universitario Antonio Pedro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes (8)
length of hospitalization
number of days of the study entry hospitalization
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
death
death after study entry hospitalization discharge
Measured: patients will be followed up to 360 days after hospital discharge
rehospitalization
need to be admitted to any hospital after study entry hospitalization discharge
Measured: 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
Measured: patients will be followed up to 360 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2012
- Study completionSep 2012
Why it stopped: problems with the stability of samples collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorenal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro-Cardiaco Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal Fluminense, Hospital Universitário Antonio Pedro, Diagnósticos da América S.A.
- Investigators
- Evandro T Mesquita, PhD, Principal investigator, Fluminense Federal University - Cardiovascular Sciences Department, coordinator of post graduation courses; Hospital PróCardíaco - Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364636
- Sponsor's protocol ID
- CYNDERELA-HF
- Acronym
- CYNDERELA-HF
- Status last verified
- Apr 2011
- First submitted
- 9 May 2011
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01364636
- Acronym / sponsor ID
- CYNDERELA-HF / CYNDERELA-HF
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: problems with the stability of samples collected
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Pro-Cardiaco HospitalUniversity, hospital or other
- Collaborators
- Universidade Federal Fluminense, Hospital Universitário Antonio Pedro, Diagnósticos da América S.A.
- Study start
- Feb 2011 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Heart Failure | – | –Patients admitted to emergency room in Acute Heart Failure at Hospital PróCardíaco and Hospital Universitario Antonio Pedro |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- acute heart failure according to the Framingham's criteria
- informed consent signed
Key exclusion criteria (7 listed)
- Acute coronary syndrome
- cardiogenic shock
- terminal renal disease
- transplanted patients
- known nephrotoxicity exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CardioRenal Syndrome type 1 development
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
CardioRenal Syndrome type 1 development defined by the elevation of serum creatinine of 0,3mg/dL and/or of 50% of baseline values
8 secondary outcomes
length of hospitalization
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
in-hospital death
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
institution of renal replacement therapy
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
need to use of vasoactive drugs
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
mechanical ventilation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
death
Time frame: patients will be followed up to 360 days after hospital discharge
rehospitalization
Time frame: patients will be followed up to 360 days after hospital discharge
institution of renal replacement therapy
Time frame: patients will be followed up to 360 days after hospital discharge
Results and safety
The study was stopped early (reason given: problems with the stability of samples collected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evandro T Mesquita, PhD principal investigator
Fluminense Federal University - Cardiovascular Sciences Department, coordinator of post graduation courses; Hospital PróCardíaco - Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiorenal Syndrome, run by Pro-Cardiaco Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: problems with the stability of samples collected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CardioRenal Syndrome type 1 development (time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.