Biomonitoring and Cardiorenal Syndrome in Heart Failure(BIONICS-HF) Trial
The purpose of this study is to evaluate the ability of a non-invasive monitor that measures how much fluid is in the body as well as various blood tests for their ability to predict worsening kidney function in patients with heart failure.
Acute Decompensated Heart Failure
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- the onset of Worsening renal function following admission [ Time Frame: From beginning of hospitalization to a follow up of 60 days ] [ Designated as safety issue: No ]
- the initiation of renal replacement therapy [ Time Frame: From beginning of hospitalization to a follow up of 60 days ] [ Designated as safety issue: No ]
- all cause mortality [ Time Frame: From beginning of hospitalization to a follow up of 60 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
10 ml sample of blood will be draw into a tube containing ethylenediaminetetraacetic acid, spun for 15 minutes, and aliquoted to freezer tubes for biomarker measurement following the completition of the trial
|Study Start Date:||March 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|