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

Mass General Brigham

Status: Completed

Conditions: Cardiorenal Syndrome; Acute Decompensated Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT01570153

2012P000312

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

ADHF patients