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Completed

NCT Number: NCT01570153

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

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.

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Key information

Conditions

Cardiorenal Syndrome Acute Decompensated Heart Failure Cardio-Renal Syndrome Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Sant'Andrea, Rome, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. the onset of Worsening renal function following admission

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

Secondary outcomes

  1. the initiation of renal replacement therapy

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

  2. all cause mortality

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study 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

Acronym: BIONICS-HF

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 4, 2012
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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