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Clinical Trials/NCT01570153
NCT01570153CompletedNot Applicable

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

Massachusetts General Hospital2 sites in 2 countries100 target enrollmentStarted: March 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
the onset of Worsening renal function following admission
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

the onset of Worsening renal function following admission

Time Frame: From beginning of hospitalization to a follow up of 60 days

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

James L. Januzzi

JANUZZI, JAMES L, MD CARDIOLOGY DIVISION CARDIAC UNIT ASSOCIATES DIRECTOR CARDIAC CARE UNIT

Massachusetts General Hospital

Study Sites (2)

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