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

Acute Decompensated Heart Failure Clinical Trial

— BIONICS-HF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570153
• Other study ID #: 2012P000312
• Status: Completed
• Phase: N/A
• First received: March 22, 2012
• Last updated: March 21, 2014
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Cardio-Renal Syndrome
• Cardiorenal Syndrome
• Heart Failure
• Syndrome

Locations

Country	Name	City	State
Italy	Ospedale Sant'Andrea	Rome
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Countries where clinical trial is conducted

United States,  Italy, 

References & Publications (22)

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. Epub 2005 Dec 9. — View Citation

Di Somma S, De Berardinis B, Bongiovanni C, Marino R, Ferri E, Alfei B. Use of BNP and bioimpedance to drive therapy in heart failure patients. Congest Heart Fail. 2010 Jul;16 Suppl 1:S56-61. doi: 10.1111/j.1751-7133.2010.00162.x. — View Citation

Dupont M, Shrestha K, Tang WH. Revisiting the cardio-renal hypothesis: the pivotal role of the kidney in congestive heart failure. Eur J Heart Fail. 2011 Aug;13(8):820-2. doi: 10.1093/eurjhf/hfr092. — View Citation

Gottlieb SS, Abraham W, Butler J, Forman DE, Loh E, Massie BM, O'connor CM, Rich MW, Stevenson LW, Young J, Krumholz HM. The prognostic importance of different definitions of worsening renal function in congestive heart failure. J Card Fail. 2002 Jun;8(3):136-41. — View Citation

Januzzi JL Jr, Peacock WF, Maisel AS, Chae CU, Jesse RL, Baggish AL, O'Donoghue M, Sakhuja R, Chen AA, van Kimmenade RR, Lewandrowski KB, Lloyd-Jones DM, Wu AH. Measurement of the interleukin family member ST2 in patients with acute dyspnea: results from the PRIDE (Pro-Brain Natriuretic Peptide Investigation of Dyspnea in the Emergency Department) study. J Am Coll Cardiol. 2007 Aug 14;50(7):607-13. Epub 2007 Jul 30. — View Citation

Maisel AS, Mueller C, Fitzgerald R, Brikhan R, Hiestand BC, Iqbal N, Clopton P, van Veldhuisen DJ. Prognostic utility of plasma neutrophil gelatinase-associated lipocalin in patients with acute heart failure: the NGAL EvaLuation Along with B-type NaTriuretic Peptide in acutely decompensated heart failure (GALLANT) trial. Eur J Heart Fail. 2011 Aug;13(8):846-51. doi: 10.1093/eurjhf/hfr087. — View Citation

Manzano-Fernández S, Januzzi JL Jr, Boronat-Garcia M, Bonaque-González JC, Truong QA, Pastor-Pérez FJ, Muñoz-Esparza C, Pastor P, Albaladejo-Otón MD, Casas T, Valdés M, Pascual-Figal DA. ß-trace protein and cystatin C as predictors of long-term outcomes in patients with acute heart failure. J Am Coll Cardiol. 2011 Feb 15;57(7):849-58. doi: 10.1016/j.jacc.2010.08.644. — View Citation

Mullens W, Abrahams Z, Francis GS, Sokos G, Taylor DO, Starling RC, Young JB, Tang WH. Importance of venous congestion for worsening of renal function in advanced decompensated heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):589-96. doi: 10.1016/j.jacc.2008.05.068. — View Citation

Mullens W, Abrahams Z, Skouri HN, Francis GS, Taylor DO, Starling RC, Paganini E, Tang WH. Elevated intra-abdominal pressure in acute decompensated heart failure: a potential contributor to worsening renal function? J Am Coll Cardiol. 2008 Jan 22;51(3):300-6. doi: 10.1016/j.jacc.2007.09.043. — View Citation

Nickolas TL, O'Rourke MJ, Yang J, Sise ME, Canetta PA, Barasch N, Buchen C, Khan F, Mori K, Giglio J, Devarajan P, Barasch J. Sensitivity and specificity of a single emergency department measurement of urinary neutrophil gelatinase-associated lipocalin for diagnosing acute kidney injury. Ann Intern Med. 2008 Jun 3;148(11):810-9. — View Citation

Parrinello G, Paterna S, Di Pasquale P, Torres D, Fatta A, Mezzero M, Scaglione R, Licata G. The usefulness of bioelectrical impedance analysis in differentiating dyspnea due to decompensated heart failure. J Card Fail. 2008 Oct;14(8):676-86. doi: 10.1016/j.cardfail.2008.04.005. Epub 2008 Jun 6. — View Citation

Peacock WF 4th. Use of bioimpedance vector analysis in critically ill and cardiorenal patients. Contrib Nephrol. 2010;165:226-35. doi: 10.1159/000313762. Epub 2010 Apr 20. — View Citation

Piccoli A, Pittoni G, Facco E, Favaro E, Pillon L. Relationship between central venous pressure and bioimpedance vector analysis in critically ill patients. Crit Care Med. 2000 Jan;28(1):132-7. — View Citation

Piccoli A. Bioelectric impedance measurement for fluid status assessment. Contrib Nephrol. 2010;164:143-52. doi: 10.1159/000313727. Epub 2010 Apr 20. — View Citation

Rehman SU, Martinez-Rumayor A, Mueller T, Januzzi JL Jr. Independent and incremental prognostic value of multimarker testing in acute dyspnea: results from the ProBNP Investigation of Dyspnea in the Emergency Department (PRIDE) study. Clin Chim Acta. 2008 Jun;392(1-2):41-5. doi: 10.1016/j.cca.2008.03.002. Epub 2008 Mar 13. — View Citation

Rehman SU, Mueller T, Januzzi JL Jr. Characteristics of the novel interleukin family biomarker ST2 in patients with acute heart failure. J Am Coll Cardiol. 2008 Oct 28;52(18):1458-65. doi: 10.1016/j.jacc.2008.07.042. — View Citation

Ronco C, McCullough PA, Anker SD, Anand I, Aspromonte N, Bagshaw SM, Bellomo R, Berl T, Bobek I, Cruz DN, Daliento L, Davenport A, Haapio M, Hillege H, House A, Katz NM, Maisel A, Mankad S, Zanco P, Mebazaa A, Palazzuoli A, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G, Zamperetti N, Ponikowski P; Acute Dialysis Quality Initiative (ADQI) consensus group. Cardiorenal syndromes: an executive summary from the consensus conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2010;165:54-67. doi: 10.1159/000313745. Epub 2010 Apr 20. — View Citation

Shah RV, Chen-Tournoux AA, Picard MH, van Kimmenade RR, Januzzi JL. Serum levels of the interleukin-1 receptor family member ST2, cardiac structure and function, and long-term mortality in patients with acute dyspnea. Circ Heart Fail. 2009 Jul;2(4):311-9. doi: 10.1161/CIRCHEARTFAILURE.108.833707. Epub 2009 May 14. — View Citation

Singer E, Elger A, Elitok S, Kettritz R, Nickolas TL, Barasch J, Luft FC, Schmidt-Ott KM. Urinary neutrophil gelatinase-associated lipocalin distinguishes pre-renal from intrinsic renal failure and predicts outcomes. Kidney Int. 2011 Aug;80(4):405-14. doi: 10.1038/ki.2011.41. Epub 2011 Mar 16. — View Citation

Tang WH, Mullens W. Cardiorenal syndrome in decompensated heart failure. Heart. 2010 Feb;96(4):255-60. doi: 10.1136/hrt.2009.166256. Epub 2009 Apr 27. Review. — View Citation

van Kimmenade RR, Januzzi JL Jr, Baggish AL, Lainchbury JG, Bayes-Genis A, Richards AM, Pinto YM. Amino-terminal pro-brain natriuretic Peptide, renal function, and outcomes in acute heart failure: redefining the cardiorenal interaction? J Am Coll Cardiol. 2006 Oct 17;48(8):1621-7. Epub 2006 Sep 27. — View Citation

van Kimmenade RR, Pinto Y, Januzzi JL Jr. When renal and cardiac insufficiencies intersect: is there a role for natriuretic peptide testing in the 'cardio-renal syndrome'? Eur Heart J. 2007 Dec;28(24):2960-1. Epub 2007 Nov 5. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the onset of Worsening renal function following admission		From beginning of hospitalization to a follow up of 60 days	No
Secondary	the initiation of renal replacement therapy		From beginning of hospitalization to a follow up of 60 days	No
Secondary	all cause mortality		From beginning of hospitalization to a follow up of 60 days	No