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

Completed

• Conditions: Cardiorenal Syndrome; Acute Decompensated Heart Failure

• Registration Number: NCT01570153
• Lead Sponsor: Massachusetts General Hospital

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 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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Primary Completion: 2012-07
• Study Completion: 2013-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the onset of Worsening renal function following admission	From beginning of hospitalization to a follow up of 60 days

Secondary Outcome Measures

Name	Time	Method
all cause mortality	From beginning of hospitalization to a follow up of 60 days
the initiation of renal replacement therapy	From beginning of hospitalization to a follow up of 60 days

Trial Locations

Locations (2)

Ospedale Sant'Andrea; 🇮🇹 Rome, Italy

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States