NCT01570153

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cardiorenal Syndrome
• Acute Decompensated Heart Failure

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-07-01
• Completion: 2013-11-01
• First posted: 2012-04-04
• Last updated: 2014-03-24

Locations

2 sites across 2 countries: United States, Italy