Biomonitoring and Cardiorenal Syndrome in Heart Failure(BIONICS-HF) Trial (BIONICS-HF)
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|ClinicalTrials.gov Identifier: NCT01570153|
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : March 24, 2014
|Condition or disease|
|Cardiorenal Syndrome Acute Decompensated Heart Failure|
Our specific aims are to:
- Evaluate the individual and collective ability of pro-B type natriuretic peptide (NT-pro-BNP), soluble (s)ST2, neutrophil gelatinase-associated lipocalin (NGAL), and bioelectrical impedance vector analysis (BIVA) for predicting in-hospital worsening renal function (WRF) in patients evaluated in emergency department (ED)with acutely decompensated heart failure (ADHF)compared to a model of clinical variables alone.
- Evaluate the individual and collective ability of NT-proBNP, sST2, NGAL, and BIVA for identifying the correct cause of in-hospital WRF in patients evaluated in the ED with ADHF.
- Evaluate the individual and collective ability of NT-pro-BNP, sST2, NGAL, and BIVA for predicting outcomes (all-cause death, all-cause re-hospitalization, initiation of renal replacement therapy by 180 days) in patients with ADHF.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Biomarkers Plus Bioimpedance Vector Analysis to Predict Cardiorenal Syndrome Onset and Prognosis in Patients With Acutely Decompensated Heart Failure: Biomonitoring and Cardiorenal Syndrome in Heart Failure(BIONICS-HF) Trial|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||November 2013|
- the onset of Worsening renal function following admission [ Time Frame: From beginning of hospitalization to a follow up of 60 days ]
- the initiation of renal replacement therapy [ Time Frame: From beginning of hospitalization to a follow up of 60 days ]
- all cause mortality [ Time Frame: From beginning of hospitalization to a follow up of 60 days ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570153
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Rome, Italy, 00189|
|Principal Investigator:||James L Januzzi, MD||Cardiology Division/Cardiac Unit Associated Director Cardiac Care Unit|