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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James L. Januzzi, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01570153
First received: March 22, 2012
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition
Cardiorenal Syndrome
Acute Decompensated Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • the onset of Worsening renal function following admission [ Time Frame: From beginning of hospitalization to a follow up of 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the initiation of renal replacement therapy [ Time Frame: From beginning of hospitalization to a follow up of 60 days ] [ Designated as safety issue: No ]
  • all cause mortality [ Time Frame: From beginning of hospitalization to a follow up of 60 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

10 ml sample of blood will be draw into a tube containing ethylenediaminetetraacetic acid, spun for 15 minutes, and aliquoted to freezer tubes for biomarker measurement following the completition of the trial


Enrollment: 100
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ADHF patients

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570153

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Italy
Ospedale Sant'Andrea
Rome, Italy, 00189
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: James L Januzzi, MD Cardiology Division/Cardiac Unit Associated Director Cardiac Care Unit
  More Information

Publications:

Responsible Party: James L. Januzzi, JANUZZI, JAMES L, MD CARDIOLOGY DIVISION CARDIAC UNIT ASSOCIATES DIRECTOR CARDIAC CARE UNIT, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01570153     History of Changes
Other Study ID Numbers: 2012P000312
Study First Received: March 22, 2012
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014