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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiorenal Syndrome
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- the onset of Worsening renal function following admission
- Status
- Completed
- Last Updated
- 12 years ago
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.
Investigators
James L. Januzzi
JANUZZI, JAMES L, MD CARDIOLOGY DIVISION CARDIAC UNIT ASSOCIATES DIRECTOR CARDIAC CARE UNIT
Massachusetts General Hospital
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
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)