Biomonitoring and Cardiorenal Syndrome in Heart Failure(B... | NCT01570153

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

NCT01570153

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Mar 24, 2014Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Cardiorenal Syndrome
Acute Decompensated Heart Failure

Interventions

Not provided

Countries

United States
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jul 2012Actual

Completion Date

Nov 2013Actual

First Submitted Date

Mar 22, 2012

First Submission Date that Met QC Criteria

Apr 2, 2012

First Posted Date

Apr 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2014

Last Update Posted Date

Mar 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

James L. Januzzi, JANUZZI, JAMES L, MD CARDIOLOGY DIVISION CARDIAC UNIT ASSOCIATES DIRECTOR CARDIAC CARE UNIT, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.
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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Label	Type	Description	Intervention Names
ADHF patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James L Januzzi, MD	Cardiology Division/Cardiac Unit Associated Director Cardiac Care Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Ospedale Sant'Andrea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16386670	Background	Anwaruddin S, Lloyd-Jones DM, Baggish A, Chen A, Krauser D, Tung R, Chae C, Januzzi JL Jr. Renal function, congestive heart failure, and amino-terminal pro-brain natriuretic peptide measurement: results from the ProBNP Investigation of Dyspnea in the Emergency Department (PRIDE) Study. J Am Coll Cardiol. 2006 Jan 3;47(1):91-7. doi: 10.1016/j.jacc.2005.08.051. Epub 2005 Dec 9.
21310322

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases