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

March 21, 2014 updated by: James L. Januzzi, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00189
        • Ospedale Sant'Andrea
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting to the Emergency Department of the Massachusetts General Hospital with complaints compatible with Acute Decompensated Heart Failure (ADHF)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ADHF patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
the initiation of renal replacement therapy
Time Frame: From beginning of hospitalization to a follow up of 60 days
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
From beginning of hospitalization to a follow up of 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: James L Januzzi, MD, Cardiology Division/Cardiac Unit Associated Director Cardiac Care Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P000312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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