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

NCT ID: NCT01570153

Last Updated: 2014-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-11-30

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.

Conditions

Cardiorenal Syndrome; Acute Decompensated Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ADHF patients

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

James L. Januzzi

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James L Januzzi, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Division/Cardiac Unit Associated Director Cardiac Care Unit

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Ospedale Sant'Andrea

Rome, , Italy

Countries

United States; Italy

References

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Other Identifiers

2012P000312

Identifier Type: -

Identifier Source: org_study_id