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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Biomarkers Plus Bioimpedance Vector Analysis to Predict Cardiorenal Syndrome Onset and Prognosis in Patients With Acutely Decompensated Heart Failure: Biomonitoring and

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Massachusetts General Hospital

Current Primary Outcome: the onset of Worsening renal function following admission [ Time Frame: From beginning of hospitalization to a follow up of 60 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: March 22, 2012
Date Started: March 2012
Date Completion:
Last Updated: March 21, 2014
Last Verified: March 2014