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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01570153

Acronym

BIONICS-HF

Enrollment

100

Registered

2012-04-04

Start date

2012-03-31

Completion date

2013-11-30

Last updated

2014-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Decompensated Heart Failure, Cardiorenal Syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy, United States

Outcome results