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Biomonitoring and Cardiorenal Syndrome in Heart Failure(BIONICS-HF) Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James L. Januzzi, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01570153
First received: March 22, 2012
Last updated: March 21, 2014
Last verified: March 2014

March 22, 2012
March 21, 2014
March 2012
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01570153 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Biomonitoring and Cardiorenal Syndrome in Heart Failure(BIONICS-HF) Trial
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 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.

Our specific aims are to:

  1. 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.
  2. 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.
  3. 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Probability Sample

Patients presenting to the Emergency Department of the Massachusetts General Hospital with complaints compatible with Acute Decompensated Heart Failure (ADHF)

  • Cardiorenal Syndrome
  • Acute Decompensated Heart Failure
Not Provided
ADHF patients

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2013
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Dyspnea thought to be due to ADHF
  • NYHA class III or IV symptoms

Exclusion Criteria:

  • renal failure requiring renal replacement therapy rior to enrollment
  • unable or unwilling to participate
  • > 6 hours from first dose of intravenous diuretic
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy
 
NCT01570153
2012P000312
Yes
James L. Januzzi, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: James L Januzzi, MD Cardiology Division/Cardiac Unit Associated Director Cardiac Care Unit
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP