Lithuanian Echocardiography Study of Dyspnea in Acute Settings

NCT03048032 | Completed

• 2 other identifiers: MIP-049/2015L-15-01/1
• Study Type: observational
• Target: 1,566
• Locations: 2 countries
• Sites: 3

Brief Summary

LEDA (Lithuanian Echocardiography study of Dyspnea in Acute settings) is a prospective observational cohort multicenter clinical study. Project is carried out by Vilnius University together with a partner Lithuanian University of Health Sciences, in conjunction with a research protocol of international GREAT consortium (Global Research on Acute Conditions Team). The aim of this project is to find the specific novel biomarkers of acute heart failure (AHF), to evaluate their diagnostic and prognostic role in association with echocardiographic parameters of AHF. Primary endpoint is 1-year all-cause mortality and rehospitalization. Secondary endpoints are 1) in-hospital all-cause mortality 2) post-discharge 1 and 3 month all-cause mortality and rehospitalization 3) post-discharge 1 and 3 month cardiovascular mortality and rehospitalization 4) one-year cardiovascular mortality and rehospitalization. During the project a sizeable national database (2000 Lithuanian patients) will be integrated into database of GREAT network. Novel cardiac biomarkers together with ultrasound parameters of right ventricular (RV) function are in the focus of the study. During the acute phase of heart failure, up to 15 novel cardiac, vascular, renal impairment and inflammation biomarkers in plasma samples will be investigated in Lithuania and France (INSERM laboratory). Plasma samples will be taken during 4 hours after admission and frozen at -80ºC to allow batch analysis. The extensive evaluation of innovative ultrasound parameters of right ventricular structure and function will be performed in the early hospitalization period, along with standard echocardiography examination. The first database of AHF patients in Lithuania will provide demographic data and trends of morbidity and mortality, as well as analysis of diagnostic and prognostic value of novel biomarkers and echocardiography parameters in the Baltic region. Quantitative parameters of RV systolic function and deformation will be measured. It is expected that optimal use of novel biomarkers and reproducible echocardiography parameters in the setting of emergency and critical care would reduce unnecessary hospitalizations, cost and hospital length of stay without decrease in the quality of diagnostics and treatment. An estimation of correlation of echocardiographic parameters and biomarkers could help create an accurate algorithm for risk stratification and diagnosis of AHF in an emergency setting.

Conditions

Acute Heart Failure

Keywords

acute heart failure; right ventricular failure; cardiac biomarkers; echocardiography; diagnosis; prognosis

Outcome Measures

Primary Outcomes (1)

• 1-year all-cause mortality and rehospitalization

  The sum of all-cause deaths and all-cause rehospitalizations in AHF and non-AHF groups

  1 year

Secondary Outcomes (4)

• In-hospital all-cause mortality

  28 days

• Post-discharge all-cause mortality and rehospitalization

  1 and 3 months

• Post-discharge cardiovascular mortality and rehospitalization

  1 and 3 months

• 1-year cardiovascular mortality and rehospitalization

  1 year

Other Outcomes (2)

• Prognostic role of circulating biomarkers

  1 year

• Prognostic role of echocardiographic parameters

  1 year

Study Arms (2)

Acute heart failure patients

Adult patients (18 years and older) who are admitted to the emergency department (Vilnius University Hospital Santariškių Klinikos and Hospital of Lithuanian University of Health Sciences Kauno Klinikos) due to acute dyspnea and have an adjudicated diagnosis of acute heart failure. Blood sampling and echocardiography examination will be performed.

Procedure: Blood sampling; Procedure: Echocardiography exam

Control group

Patients who are admitted to the emergency departments of participating centers due to acute dyspnea with an adjudicated diagnosis other than heart failure (pulmonary causes of dyspnea such as pulmonary embolism, acute infections, cancer and other reasons). Blood sampling and echocardiography examination will be performed.

Procedure: Blood sampling; Procedure: Echocardiography exam

Interventions

Blood sampling PROCEDURE

Besides routine clinical, laboratory and instrumental evaluation, blood samples will be taken within 4 hours of presentation to the hospital. Plasma samples, stored and frozen at -80°C, will be analyzed at the INSERM UMR942 institute in Paris. Up to 15 novel will be measured during the study: copeptine, proenkephalin, high sensitivity troponin T, troponin I, brain natriuretic peptide (BNP), N-terminal pro-BNP, adrenomedullin, soluble ST2, galectine 3, C-reactive protein, interleukine 6, procalcitonin, cystatin C, neutrophil gelatinase associated lipocalin.

Acute heart failure patients; Control group

Echocardiography exam PROCEDURE

A standard echocardiography as well as examination focused on right ventricle (RV) will be performed in a period of 48 hours of admission. Novel qualitative and quantitative parameters of right ventricle function and structure will be measured. These include RV diameter at base and midlevel, a measure of RV fractional area change (FAC), tissue doppler imaging derived tricuspid lateral annular systolic velocity wave (S'), tricuspid annular plane systolic excursion (TAPSE), velocity and gradient of tricuspid regurgitation, estimated systolic RV and RA pressure, RV wall strain and strain rate.

Acute heart failure patients; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (18 years and older) who present to the hospital (Vilnius University hospital Santariškių Klinikos and Hospital of Lithuanian University of Health Sciences Kauno Klinikos) due to acute dyspnea. Besides acute heart failure, patients with pulmonary causes of dyspnea as well as pulmonary embolism, acute infections, cancer and other reasons are enrolled. Patients admitted to the ward as well as and discharged home from the emergency department are enrolled.

You may qualify if:

• presentation to hospital with acute dyspnea.

You may not qualify if:

• refusal to give informed consent; acute coronary syndromes.

Sponsors & Collaborators

• Vilnius University: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Lithuanian University of Health Sciences: collaborator

Study Sites (3)

Inserm U942

Paris, Île-de-France Region, 75475, France

Location

Lithuanian University of Health Sciences

Kaunas, 50009, Lithuania

Location

Vilnius University

Vilnius, 08406, Lithuania

Location

Related Publications (63)

• Kaur M, Sprague S, Ignacy T, Thoma A, Bhandari M, Farrokhyar F. How to optimize participant retention and complete follow-up in surgical research. Can J Surg. 2014 Dec;57(6):420-7. doi: 10.1503/cjs.006314. No abstract available.

  PMID: 25421086 BACKGROUND

• Lasagna L. Problems in publication of clinical trial methodology. Clin Pharmacol Ther. 1979 May;25(5 Pt 2):751-3. doi: 10.1002/cpt1979255part2751.

  PMID: 373967 BACKGROUND

• Gullen WH, Bearman JE, Calvert JC, Loewenson RB. Medical statistics: unscrambling the clinical research egg. Patient Care. 1978 May 30;12(10):120-2, 127, 130-2 passim. No abstract available.

  PMID: 10236742 BACKGROUND

• Julious SA, Owen RJ. Sample size calculations for clinical studies allowing for uncertainty about the variance. Pharm Stat. 2006 Jan-Mar;5(1):29-37. doi: 10.1002/pst.197.

  PMID: 17080926 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

  PMID: 27207191 BACKGROUND

• Zannad F, Mebazaa A, Juilliere Y, Cohen-Solal A, Guize L, Alla F, Rouge P, Blin P, Barlet MH, Paolozzi L, Vincent C, Desnos M, Samii K; EFICA Investigators. Clinical profile, contemporary management and one-year mortality in patients with severe acute heart failure syndromes: The EFICA study. Eur J Heart Fail. 2006 Nov;8(7):697-705. doi: 10.1016/j.ejheart.2006.01.001. Epub 2006 Mar 3.

  PMID: 16516552 BACKGROUND

• Maisel AS, Peacock WF, McMullin N, Jessie R, Fonarow GC, Wynne J, Mills RM. Timing of immunoreactive B-type natriuretic peptide levels and treatment delay in acute decompensated heart failure: an ADHERE (Acute Decompensated Heart Failure National Registry) analysis. J Am Coll Cardiol. 2008 Aug 12;52(7):534-40. doi: 10.1016/j.jacc.2008.05.010.

  PMID: 18687247 BACKGROUND

• Emerman CL. Treatment of the acute decompensation of heart failure: efficacy and pharmacoeconomics of early initiation of therapy in the emergency department. Rev Cardiovasc Med. 2003;4 Suppl 7:S13-20.

  PMID: 14668696 BACKGROUND

• Peacock WF, Emerman C, Costanzo MR, Diercks DB, Lopatin M, Fonarow GC. Early vasoactive drugs improve heart failure outcomes. Congest Heart Fail. 2009 Nov-Dec;15(6):256-64. doi: 10.1111/j.1751-7133.2009.00112.x.

  PMID: 19925503 BACKGROUND

• Masip J, Roque M, Sanchez B, Fernandez R, Subirana M, Exposito JA. Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic review and meta-analysis. JAMA. 2005 Dec 28;294(24):3124-30. doi: 10.1001/jama.294.24.3124.

  PMID: 16380593 BACKGROUND

• Maisel AS, McCord J, Nowak RM, Hollander JE, Wu AH, Duc P, Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg G, Aumont MC, Westheim A, Knudsen CW, Perez A, Kamin R, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Bedside B-Type natriuretic peptide in the emergency diagnosis of heart failure with reduced or preserved ejection fraction. Results from the Breathing Not Properly Multinational Study. J Am Coll Cardiol. 2003 Jun 4;41(11):2010-7. doi: 10.1016/s0735-1097(03)00405-4.

  PMID: 12798574 BACKGROUND

• Januzzi JL Jr, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, Tung R, Cameron R, Nagurney JT, Chae CU, Lloyd-Jones DM, Brown DF, Foran-Melanson S, Sluss PM, Lee-Lewandrowski E, Lewandrowski KB. The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005 Apr 15;95(8):948-54. doi: 10.1016/j.amjcard.2004.12.032.

  PMID: 15820160 BACKGROUND

• Peacock WF 4th, De Marco T, Fonarow GC, Diercks D, Wynne J, Apple FS, Wu AH; ADHERE Investigators. Cardiac troponin and outcome in acute heart failure. N Engl J Med. 2008 May 15;358(20):2117-26. doi: 10.1056/NEJMoa0706824.

  PMID: 18480204 BACKGROUND

• Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

  PMID: 23186936 BACKGROUND

• Chioncel O, Ambrosy AP, Bubenek S, Filipescu D, Vinereanu D, Petris A, Christodorescu R, Macarie C, Gheorghiade M, Collins SP; Romanian Acute Heart Failure Syndromes study investigators. Epidemiology, pathophysiology, and in-hospital management of pulmonary edema: data from the Romanian Acute Heart Failure Syndromes registry. J Cardiovasc Med (Hagerstown). 2016 Feb;17(2):92-104. doi: 10.2459/JCM.0000000000000192.

  PMID: 25252041 BACKGROUND

• Belohlavek J, Dytrych V, Linhart A. Pulmonary embolism, part I: Epidemiology, risk factors and risk stratification, pathophysiology, clinical presentation, diagnosis and nonthrombotic pulmonary embolism. Exp Clin Cardiol. 2013 Spring;18(2):129-38.

  PMID: 23940438 BACKGROUND

• Kinch JW, Ryan TJ. Right ventricular infarction. N Engl J Med. 1994 Apr 28;330(17):1211-7. doi: 10.1056/NEJM199404283301707.

  PMID: 8139631 BACKGROUND

• Naeije R, Brimioulle S, Dewachter L. Biomechanics of the right ventricle in health and disease (2013 Grover Conference series). Pulm Circ. 2014 Sep;4(3):395-406. doi: 10.1086/677354.

  PMID: 25621153 BACKGROUND

• Berlin DA, Bakker J. Understanding venous return. Intensive Care Med. 2014 Oct;40(10):1564-6. doi: 10.1007/s00134-014-3379-4. Epub 2014 Jun 26. No abstract available.

  PMID: 24966066 BACKGROUND

• Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: I. Anatomy, physiology, and assessment. Anesth Analg. 2009 Feb;108(2):407-21. doi: 10.1213/ane.0b013e31818f8623.

  PMID: 19151264 BACKGROUND

• Markel TA, Wairiuko GM, Lahm T, Crisostomo PR, Wang M, Herring CM, Meldrum DR. The right heart and its distinct mechanisms of development, function, and failure. J Surg Res. 2008 May 15;146(2):304-13. doi: 10.1016/j.jss.2007.04.003. Epub 2007 Nov 26.

  PMID: 18036544 BACKGROUND

• Mullens W, Abrahams Z, Francis GS, Sokos G, Taylor DO, Starling RC, Young JB, Tang WHW. Importance of venous congestion for worsening of renal function in advanced decompensated heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):589-596. doi: 10.1016/j.jacc.2008.05.068.

  PMID: 19215833 BACKGROUND

• Lankeit M, Jimenez D, Kostrubiec M, Dellas C, Hasenfuss G, Pruszczyk P, Konstantinides S. Predictive value of the high-sensitivity troponin T assay and the simplified Pulmonary Embolism Severity Index in hemodynamically stable patients with acute pulmonary embolism: a prospective validation study. Circulation. 2011 Dec 13;124(24):2716-24. doi: 10.1161/CIRCULATIONAHA.111.051177. Epub 2011 Nov 14.

  PMID: 22082681 BACKGROUND

• Sztrymf B, Souza R, Bertoletti L, Jais X, Sitbon O, Price LC, Simonneau G, Humbert M. Prognostic factors of acute heart failure in patients with pulmonary arterial hypertension. Eur Respir J. 2010 Jun;35(6):1286-93. doi: 10.1183/09031936.00070209. Epub 2009 Nov 6.

  PMID: 19897557 BACKGROUND

• Naito A, Tanabe N, Jujo T, Shigeta A, Sugiura T, Sakao S, Ishida K, Tatsumi K. Pentraxin3 in chronic thromboembolic pulmonary hypertension: a new biomarker for screening from remitted pulmonary thromboembolism. PLoS One. 2014 Nov 20;9(11):e113086. doi: 10.1371/journal.pone.0113086. eCollection 2014.

  PMID: 25412085 BACKGROUND

• Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.

  PMID: 20620859 BACKGROUND

• Ghignone M, Girling L, Prewitt RM. Volume expansion versus norepinephrine in treatment of a low cardiac output complicating an acute increase in right ventricular afterload in dogs. Anesthesiology. 1984 Feb;60(2):132-5. doi: 10.1097/00000542-198402000-00009.

  PMID: 6198941 BACKGROUND

• Zannad F, Adamopoulos C, Mebazaa A, Gheorghiade M. The challenge of acute decompensated heart failure. Heart Fail Rev. 2006 Jun;11(2):135-9. doi: 10.1007/s10741-006-9484-x.

  PMID: 16937032 BACKGROUND

• Ng TM, Singh AK, Dasta JF, Feldman D, Mebazaa A. Contemporary issues in the pharmacologic management of acute heart failure. Crit Care Clin. 2006 Apr;22(2):199-219, v. doi: 10.1016/j.ccc.2006.02.008.

  PMID: 16677996 BACKGROUND

• De Luca L, Fonarow GC, Adams KF Jr, Mebazaa A, Tavazzi L, Swedberg K, Gheorghiade M. Acute heart failure syndromes: clinical scenarios and pathophysiologic targets for therapy. Heart Fail Rev. 2007 Jun;12(2):97-104. doi: 10.1007/s10741-007-9011-8.

  PMID: 17487581 BACKGROUND

• Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, Pocock SJ, Thakkar R, Padley RJ, Poder P, Kivikko M; SURVIVE Investigators. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial. JAMA. 2007 May 2;297(17):1883-91. doi: 10.1001/jama.297.17.1883.

  PMID: 17473298 BACKGROUND

• Adamopoulos C, Zannad F, Fay R, Mebazaa A, Cohen-Solal A, Guize L, Juilliere Y, Alla F. Ejection fraction and blood pressure are important and interactive predictors of 4-week mortality in severe acute heart failure. Eur J Heart Fail. 2007 Sep;9(9):935-41. doi: 10.1016/j.ejheart.2007.06.001. Epub 2007 Jul 12.

  PMID: 17627880 BACKGROUND

• Pang PS, Cleland JG, Teerlink JR, Collins SP, Lindsell CJ, Sopko G, Peacock WF, Fonarow GC, Aldeen AZ, Kirk JD, Storrow AB, Tavares M, Mebazaa A, Roland E, Massie BM, Maisel AS, Komajda M, Filippatos G, Gheorghiade M; Acute Heart Failure Syndromes International Working Group. A proposal to standardize dyspnoea measurement in clinical trials of acute heart failure syndromes: the need for a uniform approach. Eur Heart J. 2008 Mar;29(6):816-24. doi: 10.1093/eurheartj/ehn048. Epub 2008 Mar 1.

  PMID: 18310669 BACKGROUND

• Huvelle E, Fay R, Alla F, Cohen Solal A, Mebazaa A, Zannad F. Left bundle branch block and mortality in patients with acute heart failure syndrome: a substudy of the EFICA cohort. Eur J Heart Fail. 2010 Feb;12(2):156-63. doi: 10.1093/eurjhf/hfp180. Epub 2009 Dec 21.

  PMID: 20028696 BACKGROUND

• Mebazaa A, Pang PS, Tavares M, Collins SP, Storrow AB, Laribi S, Andre S, Mark Courtney D, Hasa J, Spinar J, Masip J, Frank Peacock W, Sliwa K, Gayat E, Filippatos G, Cleland JG, Gheorghiade M. The impact of early standard therapy on dyspnoea in patients with acute heart failure: the URGENT-dyspnoea study. Eur Heart J. 2010 Apr;31(7):832-41. doi: 10.1093/eurheartj/ehp458. Epub 2009 Nov 11.

  PMID: 19906690 BACKGROUND

• Bohm M, Link A, Cai D, Nieminen MS, Filippatos GS, Salem R, Cohen Solal A, Huang B, Padley RJ, Kivikko M, Mebazaa A. Beneficial association of beta-blocker therapy on recovery from severe acute heart failure treatment: data from the Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support trial. Crit Care Med. 2011 May;39(5):940-4. doi: 10.1097/CCM.0b013e31820a91ed.

  PMID: 21283007 BACKGROUND

• Laribi S, Aouba A, Nikolaou M, Lassus J, Cohen-Solal A, Plaisance P, Pavillon G, Jois P, Fonarow GC, Jougla E, Mebazaa A; GREAT network. Trends in death attributed to heart failure over the past two decades in Europe. Eur J Heart Fail. 2012 Mar;14(3):234-9. doi: 10.1093/eurjhf/hfr182. Epub 2012 Jan 10.

  PMID: 22237388 BACKGROUND

• Parissis JT, Rafouli-Stergiou P, Mebazaa A, Ikonomidis I, Bistola V, Nikolaou M, Meas T, Delgado J, Vilas-Boas F, Paraskevaidis I, Anastasiou-Nana M, Follath F. Acute heart failure in patients with diabetes mellitus: clinical characteristics and predictors of in-hospital mortality. Int J Cardiol. 2012 May 17;157(1):108-13. doi: 10.1016/j.ijcard.2011.11.098. Epub 2011 Dec 15.

  PMID: 22178056 BACKGROUND

• Mebazaa A, Vanpoucke G, Thomas G, Verleysen K, Cohen-Solal A, Vanderheyden M, Bartunek J, Mueller C, Launay JM, Van Landuyt N, D'Hondt F, Verschuere E, Vanhaute C, Tuytten R, Vanneste L, De Cremer K, Wuyts J, Davies H, Moerman P, Logeart D, Collet C, Lortat-Jacob B, Tavares M, Laroy W, Januzzi JL, Samuel JL, Kas K. Unbiased plasma proteomics for novel diagnostic biomarkers in cardiovascular disease: identification of quiescin Q6 as a candidate biomarker of acutely decompensated heart failure. Eur Heart J. 2012 Sep;33(18):2317-24. doi: 10.1093/eurheartj/ehs162. Epub 2012 Jun 24.

  PMID: 22733835 BACKGROUND

• Breidthardt T, Vanpoucke G, Potocki M, Mosimann T, Ziller R, Thomas G, Laroy W, Moerman P, Socrates T, Drexler B, Mebazaa A, Kas K, Mueller C. The novel marker LTBP2 predicts all-cause and pulmonary death in patients with acute dyspnoea. Clin Sci (Lond). 2012 Nov;123(9):557-66. doi: 10.1042/CS20120058.

  PMID: 22587491 BACKGROUND

• Mebazaa A, Gayat E, Lassus J, Meas T, Mueller C, Maggioni A, Peacock F, Spinar J, Harjola VP, van Kimmenade R, Pathak A, Mueller T, Tavazzi L, Disomma S, Metra M, Pascual-Figal D, Laribi S, Logeart D, Nouira S, Sato N, Parenica J, Deye N, Boukef R, Collet C, Van den Berghe G, Cohen-Solal A, Januzzi JL Jr; GREAT Network. Association between elevated blood glucose and outcome in acute heart failure: results from an international observational cohort. J Am Coll Cardiol. 2013 Feb 26;61(8):820-9. doi: 10.1016/j.jacc.2012.11.054. Epub 2013 Jan 16.

  PMID: 23333145 BACKGROUND

• Lassus J, Gayat E, Mueller C, Peacock WF, Spinar J, Harjola VP, van Kimmenade R, Pathak A, Mueller T, Disomma S, Metra M, Pascual-Figal D, Laribi S, Logeart D, Nouira S, Sato N, Potocki M, Parenica J, Collet C, Cohen-Solal A, Januzzi JL Jr, Mebazaa A; GREAT-Network. Incremental value of biomarkers to clinical variables for mortality prediction in acutely decompensated heart failure: the Multinational Observational Cohort on Acute Heart Failure (MOCA) study. Int J Cardiol. 2013 Oct 3;168(3):2186-94. doi: 10.1016/j.ijcard.2013.01.228. Epub 2013 Mar 26.

  PMID: 23538053 BACKGROUND

• Seronde MF, Gayat E, Logeart D, Lassus J, Laribi S, Boukef R, Sibellas F, Launay JM, Manivet P, Sadoune M, Nouira S, Solal AC, Mebazaa A; Great network. Comparison of the diagnostic and prognostic values of B-type and atrial-type natriuretic peptides in acute heart failure. Int J Cardiol. 2013 Oct 9;168(4):3404-11. doi: 10.1016/j.ijcard.2013.04.164. Epub 2013 May 14.

  PMID: 23684562 BACKGROUND

• Shah R, Gayat E, Januzzi JL Jr, Sato N, Cohen-Solal A, diSomma S, Fairman E, Harjola VP, Ishihara S, Lassus J, Maggioni A, Metra M, Mueller C, Mueller T, Parenica J, Pascual-Figal D, Peacock WF, Spinar J, van Kimmenade R, Mebazaa A; GREAT (Global Research on Acute Conditions Team) Network. Body mass index and mortality in acutely decompensated heart failure across the world: a global obesity paradox. J Am Coll Cardiol. 2014 Mar 4;63(8):778-85. doi: 10.1016/j.jacc.2013.09.072. Epub 2013 Dec 4.

  PMID: 24315906 BACKGROUND

• Cohen AT, Spiro TE, Spyropoulos AC, Desanctis YH, Homering M, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Tapson VF, Burton P; MAGELLAN Study Group. D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial. J Thromb Haemost. 2014 Apr;12(4):479-87. doi: 10.1111/jth.12515.

  PMID: 24460645 BACKGROUND

• Pang PS, Collins SP, Sauser K, Andrei AC, Storrow AB, Hollander JE, Tavares M, Spinar J, Macarie C, Raev D, Nowak R, Gheorghiade M, Mebazaa A. Assessment of dyspnea early in acute heart failure: patient characteristics and response differences between likert and visual analog scales. Acad Emerg Med. 2014 Jun;21(6):659-66. doi: 10.1111/acem.12390.

  PMID: 25039550 BACKGROUND

• Mebazaa A, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Merli G, Schellong SW, Spyropoulos AC, Tapson VF, De Sanctis Y, Cohen AT. Predicting the risk of venous thromboembolism in patients hospitalized with heart failure. Circulation. 2014 Jul 29;130(5):410-8. doi: 10.1161/CIRCULATIONAHA.113.003126. Epub 2014 Jun 26.

  PMID: 24970782 BACKGROUND

• Vodovar N, Seronde MF, Laribi S, Gayat E, Lassus J, Boukef R, Nouira S, Manivet P, Samuel JL, Logeart D, Ishihara S, Cohen Solal A, Januzzi JL Jr, Richards AM, Launay JM, Mebazaa A; GREAT Network. Post-translational modifications enhance NT-proBNP and BNP production in acute decompensated heart failure. Eur Heart J. 2014 Dec 21;35(48):3434-41. doi: 10.1093/eurheartj/ehu314. Epub 2014 Aug 24.

  PMID: 25157115 BACKGROUND

• Cohen-Solal A, Laribi S, Ishihara S, Vergaro G, Baudet M, Logeart D, Mebazaa A, Gayat E, Vodovar N, Pascual-Figal DA, Seronde MF. Prognostic markers of acute decompensated heart failure: the emerging roles of cardiac biomarkers and prognostic scores. Arch Cardiovasc Dis. 2015 Jan;108(1):64-74. doi: 10.1016/j.acvd.2014.10.002. Epub 2014 Nov 4.

  PMID: 25534886 BACKGROUND

• Parissis JT, Andreoli C, Kadoglou N, Ikonomidis I, Farmakis D, Dimopoulou I, Iliodromitis E, Anastasiou-Nana M, Lainscak M, Ambrosio G, Mebazaa A, Filippatos G, Follath F. Differences in clinical characteristics, management and short-term outcome between acute heart failure patients chronic obstructive pulmonary disease and those without this co-morbidity. Clin Res Cardiol. 2014 Sep;103(9):733-41. doi: 10.1007/s00392-014-0708-0. Epub 2014 Apr 10.

  PMID: 24718849 BACKGROUND

• Legrand M, Mebazaa A, Ronco C, Januzzi JL Jr. When cardiac failure, kidney dysfunction, and kidney injury intersect in acute conditions: the case of cardiorenal syndrome. Crit Care Med. 2014 Sep;42(9):2109-17. doi: 10.1097/CCM.0000000000000404.

  PMID: 24810531 BACKGROUND

• Kelly JP, Mentz RJ, Mebazaa A, Voors AA, Butler J, Roessig L, Fiuzat M, Zannad F, Pitt B, O'Connor CM, Lam CSP. Patient selection in heart failure with preserved ejection fraction clinical trials. J Am Coll Cardiol. 2015 Apr 28;65(16):1668-1682. doi: 10.1016/j.jacc.2015.03.043.

  PMID: 25908073 BACKGROUND

• Mebazaa A, Yilmaz MB, Levy P, Ponikowski P, Peacock WF, Laribi S, Ristic AD, Lambrinou E, Masip J, Riley JP, McDonagh T, Mueller C, deFilippi C, Harjola VP, Thiele H, Piepoli MF, Metra M, Maggioni A, McMurray J, Dickstein K, Damman K, Seferovic PM, Ruschitzka F, Leite-Moreira AF, Bellou A, Anker SD, Filippatos G. Recommendations on pre-hospital & early hospital management of acute heart failure: a consensus paper from the Heart Failure Association of the European Society of Cardiology, the European Society of Emergency Medicine and the Society of Academic Emergency Medicine. Eur J Heart Fail. 2015 Jun;17(6):544-58. doi: 10.1002/ejhf.289. Epub 2015 May 21.

  PMID: 25999021 BACKGROUND

• Mebazaa A, Longrois D, Metra M, Mueller C, Richards AM, Roessig L, Seronde MF, Sato N, Stockbridge NL, Gattis Stough W, Alonso A, Cody RJ, Cook Bruns N, Gheorghiade M, Holzmeister J, Laribi S, Zannad F. Agents with vasodilator properties in acute heart failure: how to design successful trials. Eur J Heart Fail. 2015 Jul;17(7):652-64. doi: 10.1002/ejhf.294. Epub 2015 Jun 4.

  PMID: 26040488 BACKGROUND

• Jaffe AS, Apple FS, Mebazaa A, Vodovar N. Unraveling N-terminal pro-B-type natriuretic peptide: another piece to a very complex puzzle in heart failure patients. Clin Chem. 2015 Aug;61(8):1016-8. doi: 10.1373/clinchem.2015.243626. Epub 2015 Jun 15. No abstract available.

  PMID: 26078443 BACKGROUND

• Gayat E, Caillard A, Laribi S, Mueller C, Sadoune M, Seronde MF, Maisel A, Bartunek J, Vanderheyden M, Desutter J, Dendale P, Thomas G, Tavares M, Cohen-Solal A, Samuel JL, Mebazaa A. Soluble CD146, a new endothelial biomarker of acutely decompensated heart failure. Int J Cardiol. 2015 Nov 15;199:241-7. doi: 10.1016/j.ijcard.2015.07.039. Epub 2015 Jul 12.

  PMID: 26209827 BACKGROUND

• Vodovar N, Seronde MF, Laribi S, Gayat E, Lassus J, Januzzi JL Jr, Boukef R, Nouira S, Manivet P, Samuel JL, Logeart D, Cohen-Solal A, Richards AM, Launay JM, Mebazaa A; GREAT Network. Elevated Plasma B-Type Natriuretic Peptide Concentrations Directly Inhibit Circulating Neprilysin Activity in Heart Failure. JACC Heart Fail. 2015 Aug;3(8):629-36. doi: 10.1016/j.jchf.2015.03.011.

  PMID: 26251090 BACKGROUND

• Teixeira A, Parenica J, Park JJ, Ishihara S, AlHabib KF, Laribi S, Maggioni A, Miro O, Sato N, Kajimoto K, Cohen-Solal A, Fairman E, Lassus J, Mueller C, Peacock WF, Januzzi JL Jr, Choi DJ, Plaisance P, Spinar J, Mebazaa A, Gayat E; GREAT (Global Research on Acute Conditions Team) Network. Clinical presentation and outcome by age categories in acute heart failure: results from an international observational cohort. Eur J Heart Fail. 2015 Nov;17(11):1114-23. doi: 10.1002/ejhf.330. Epub 2015 Sep 30.

  PMID: 26419908 BACKGROUND

• Spinar J, Jarkovsky J, Spinarova L, Mebazaa A, Gayat E, Vitovec J, Linhart A, Widimsky P, Miklik R, Zeman K, Belohlavek J, Malek F, Felsoci M, Kettner J, Ostadal P, Cihalik C, Vaclavik J, Taborsky M, Dusek L, Littnerova S, Parenica J. AHEAD score--Long-term risk classification in acute heart failure. Int J Cardiol. 2016 Jan 1;202:21-6. doi: 10.1016/j.ijcard.2015.08.187. Epub 2015 Aug 28.

  PMID: 26386914 BACKGROUND

• Mebazaa A, Tolppanen H, Mueller C, Lassus J, DiSomma S, Baksyte G, Cecconi M, Choi DJ, Cohen Solal A, Christ M, Masip J, Arrigo M, Nouira S, Ojji D, Peacock F, Richards M, Sato N, Sliwa K, Spinar J, Thiele H, Yilmaz MB, Januzzi J. Acute heart failure and cardiogenic shock: a multidisciplinary practical guidance. Intensive Care Med. 2016 Feb;42(2):147-63. doi: 10.1007/s00134-015-4041-5. Epub 2015 Sep 14.

  PMID: 26370690 BACKGROUND

• Parissis J, Farmakis D, Kadoglou N, Ikonomidis I, Fountoulaki E, Hatziagelaki E, Deftereos S, Follath F, Mebazaa A, Lekakis J, Filippatos G. Body mass index in acute heart failure: association with clinical profile, therapeutic management and in-hospital outcome. Eur J Heart Fail. 2016 Mar;18(3):298-305. doi: 10.1002/ejhf.489. Epub 2016 Jan 28.

  PMID: 26817848 BACKGROUND

• Harjola VP, Mebazaa A, Celutkiene J, Bettex D, Bueno H, Chioncel O, Crespo-Leiro MG, Falk V, Filippatos G, Gibbs S, Leite-Moreira A, Lassus J, Masip J, Mueller C, Mullens W, Naeije R, Nordegraaf AV, Parissis J, Riley JP, Ristic A, Rosano G, Rudiger A, Ruschitzka F, Seferovic P, Sztrymf B, Vieillard-Baron A, Yilmaz MB, Konstantinides S. Contemporary management of acute right ventricular failure: a statement from the Heart Failure Association and the Working Group on Pulmonary Circulation and Right Ventricular Function of the European Society of Cardiology. Eur J Heart Fail. 2016 Mar;18(3):226-41. doi: 10.1002/ejhf.478.

  PMID: 26995592 BACKGROUND

• Van Aelst LN, Celutkiene J, Mebazaa A. Advanced heart failure: look right to prognosticate right! Eur J Heart Fail. 2016 May;18(5):573-5. doi: 10.1002/ejhf.533. No abstract available.

  PMID: 27135771 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Heart Failure; Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jelena Celutkiene, Professor

  Vilnius University

  STUDY CHAIR

• Ausra Kavoliuniene, Professor

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Alexandre Mebazaa, Professor

  INSERM, BIOmarkers in CArdioNeuroVAScular diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher and Professor in Clinic of Cardiac and Vascular Diseases, Centre of Cardiology and Angiology, Vilnius University; Senior cardiologist in Unit of Stress testing, Vilnius University hospital Santariškių Klinikos

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 9, 2017
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: November 1, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2019-2024
• Access Criteria: referral to prof. A. Mebazaa

Locations

FR (1); LI (2)