Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05204238
Registration number
NCT05204238
Ethics application status
Date submitted
10/01/2022
Date registered
24/01/2022
Titles & IDs
Public title
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Query!
Scientific title
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Query!
Secondary ID [1]
0
0
FUTURE_1.4
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
FUTURE-HIT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Heart Failure
0
0
Query!
Heart Failure With Preserved Ejection Fraction
0
0
Query!
Heart Failure With Mid Range Ejection Fraction
0
0
Query!
Heart Failure With Reduced Ejection Fraction
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Diagnosis / Prognosis - Transthoracic Echocardiography
Diagnosis / Prognosis: Transthoracic Echocardiography
LV dimensions, LV mass and indices of LV function LA area and volume Indices of diastolic function (E/A ratio, E/e' ratio) Heart valve assessment according to GL RV dimensions and indices of RV function PAPs (RV-RA gradient and vena cava dimensions and collapsibility) B-lines at lung ultrasounds (comet lung score) Speckle Tracking analysis of LV (GLS), LA (PALS) and RV (LS of free wall) Optional 3D analysis of left and right ventricle
Query!
Intervention code [1]
0
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
predictors of rehospitalization for heart failure and cardiovascular death
Query!
Assessment method [1]
0
0
The primary endpoint of the FUTURE HIT study will be to evaluate the best parameters, among clinical, labora-tory and echocardiographic variables assessed within 24 hours from the hospital admission and before discharge, that are able to predict rehospitalization for HF and cardiovascular death at 3 and 6 months, in patients admitted to the cardiology department for acute exacerbation of CHF or de novo AHF.
Query!
Timepoint [1]
0
0
3 and 6 months post discharge
Query!
Secondary outcome [1]
0
0
combined prognostic score of rehospitalization for heart failure and cardiovascular death
Query!
Assessment method [1]
0
0
Creation of a combined prognostic dimensionsless score, using the parameters that came out as statistically significant towards the primary endpoint on a multicenter basis. Higher scores mean a worse outcome.
Query!
Timepoint [1]
0
0
3 and 6 months post discharge
Query!
Secondary outcome [2]
0
0
Event analysis according to heart failure's different classes (HFpEF, HFmrEF, HFrEF)
Query!
Assessment method [2]
0
0
To analyze the events and the predictive ability of the parameters that came out as statistically significant to-wards the primary endpoint in the heart failure's different classes indicated in the guidelines (HFpEF, HFmrEF, HFrEF);
Query!
Timepoint [2]
0
0
3 and 6 months post discharge
Query!
Secondary outcome [3]
0
0
Event analysis according to genres
Query!
Assessment method [3]
0
0
To analyze the events and predictive ability of the parameters in the two genres
Query!
Timepoint [3]
0
0
3 and 6 months post discharge
Query!
Eligibility
Key inclusion criteria
* age =18 years
* admission to the cardiology departments for acute heart failure (de novo or exacerbation of chronic heart fail-ure) according to the clinical and instrumental criteria in the current ESC guidelines
* signing of the informed consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* age < 18 years
* valve prosthesis
* previous heart transplant or LVAD
* poor acoustic window.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
UNKNOWN
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/11/2022
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
998
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Blacktown Hospital, Faculty of Medicine, University of Sydney - Sydney
Query!
Recruitment postcode(s) [1]
0
0
- Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Edegem
Query!
Country [2]
0
0
Greece
Query!
State/province [2]
0
0
Athens
Query!
Country [3]
0
0
Greece
Query!
State/province [3]
0
0
Elefsína
Query!
Country [4]
0
0
Greece
Query!
State/province [4]
0
0
Kallithéa
Query!
Country [5]
0
0
Greece
Query!
State/province [5]
0
0
Piraeus
Query!
Country [6]
0
0
Greece
Query!
State/province [6]
0
0
Thessaloníki
Query!
Country [7]
0
0
Italy
Query!
State/province [7]
0
0
Milan
Query!
Country [8]
0
0
Italy
Query!
State/province [8]
0
0
Modena
Query!
Country [9]
0
0
Italy
Query!
State/province [9]
0
0
Napoli
Query!
Country [10]
0
0
Italy
Query!
State/province [10]
0
0
Novara
Query!
Country [11]
0
0
Italy
Query!
State/province [11]
0
0
Palermo
Query!
Country [12]
0
0
Italy
Query!
State/province [12]
0
0
Piacenza
Query!
Country [13]
0
0
Italy
Query!
State/province [13]
0
0
Pisa
Query!
Country [14]
0
0
Italy
Query!
State/province [14]
0
0
Salerno
Query!
Country [15]
0
0
Italy
Query!
State/province [15]
0
0
Siena
Query!
Country [16]
0
0
Mexico
Query!
State/province [16]
0
0
Mexico City
Query!
Country [17]
0
0
Netherlands
Query!
State/province [17]
0
0
Amsterdam
Query!
Country [18]
0
0
North Macedonia
Query!
State/province [18]
0
0
Skopje
Query!
Country [19]
0
0
Portugal
Query!
State/province [19]
0
0
Porto
Query!
Country [20]
0
0
Romania
Query!
State/province [20]
0
0
Bucharest
Query!
Country [21]
0
0
Spain
Query!
State/province [21]
0
0
Barcelona
Query!
Country [22]
0
0
Tunisia
Query!
State/province [22]
0
0
La Marsa
Query!
Country [23]
0
0
Turkey
Query!
State/province [23]
0
0
Ankara
Query!
Country [24]
0
0
Turkey
Query!
State/province [24]
0
0
Istanbul
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Siena
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
European Association of Cardiovascular Imaging
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Acute heart failure (AHF) is defined as rapid onset or rapid worsening of typical signs and symptoms of heart failure (HF) according to the 2016 European Society of Cardiology Guidelines. AHF is the first cause of hospitalization in people over 65 in Western countries, accounting for more than 1 million hospitalizations per year in the USA. This disease has many repercussions not only in terms of mortality and morbidity, but also in terms of resources and infrastructures necessary for these patients' treatment, which constitutes a high economic burden for the national health care system. Even with growing knowledge and means, nowadays, the prognosis of AHF is still poor and there are no proven therapies that lead to long-term benefits in terms of reduced mortality. A better management of the acute phase of decompensation, including the definition of effective diagnostic-therapeutic workup and the use of innovative drugs, could improve the course of the disease, with positive effects on the patient (gain in survival and reduction of admissions), but also on the community (containment of the overall health costs). In recent years, numerous scores have been outlined in various AHF settings, considering only a small number of parameters. Several prognostic models have been developed suggesting how difficult it is to evaluate the AHF patients' prognosis. All this effort towards the development of so numerous prognostic models is justified by the fact that, despite the evolution of treatments, the risk of re-hospitalization and of both intrahospital mortality and after discharge remains high. Several studies have investigated potential prognostic factors that could help evaluating the risk of cardiovascular events, but now there is no accurate and complete prognostic score, particularly for AHF patients. Therefore, to date there are no accurate scores or determinants of short- and medium-term prognosis that allow to improve the management of these patients. This will be an observational, prospective, multicentric, international, non-commercial (non-profit) study. The primary endpoint will be to evaluate the best parameters, among clinical, laboratory and echocardiographic variables assessed within 24 hours from the hospital admission and before discharge, that are able to predict rehospitalization for HF and cardiovascular death at 3 and 6 months, in patients admitted to the cardiology department for acute exacerbation of chronic HF or de novo AHF.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05204238
Query!
Trial related presentations / publications
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. Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available. Erratum In: Circulation. 2016 Apr 12;133(15):e599. doi: 10.1161/CIR.0000000000000409. Eriksson H, Svardsudd K, Larsson B, Ohlson LO, Tibblin G, Welin L, Wilhelmsen L. Risk factors for heart failure in the general population: the study of men born in 1913. Eur Heart J. 1989 Jul;10(7):647-56. doi: 10.1093/oxfordjournals.eurheartj.a059542. Cowie MR, Wood DA, Coats AJ, Thompson SG, Poole-Wilson PA, Suresh V, Sutton GC. Incidence and aetiology of heart failure; a population-based study. Eur Heart J. 1999 Mar;20(6):421-8. doi: 10.1053/euhj.1998.1280. Guha K, McDonagh T. Heart failure epidemiology: European perspective. Curr Cardiol Rev. 2013 May;9(2):123-7. doi: 10.2174/1573403x11309020005. Murphy NF, Simpson CR, McAlister FA, Stewart S, MacIntyre K, Kirkpatrick M, Chalmers J, Redpath A, Capewell S, McMurray JJ. National survey of the prevalence, incidence, primary care burden, and treatment of heart failure in Scotland. Heart. 2004 Oct;90(10):1129-36. doi: 10.1136/hrt.2003.029553. Corrao G, Maggioni AP. [Epidemiology of heart failure]. G Ital Cardiol (Rome). 2014 Feb;15(2 Suppl 2):10S-15S. doi: 10.1714/1465.16183. Italian. Tavazzi L, Senni M, Metra M, Gorini M, Cacciatore G, Chinaglia A, Di Lenarda A, Mortara A, Oliva F, Maggioni AP; IN-HF (Italian Network on Heart Failure) Outcome Investigators. Multicenter prospective observational study on acute and chronic heart failure: one-year follow-up results of IN-HF (Italian Network on Heart Failure) outcome registry. Circ Heart Fail. 2013 May;6(3):473-81. doi: 10.1161/CIRCHEARTFAILURE.112.000161. Epub 2013 Mar 8. Kurmani S, Squire I. Acute Heart Failure: Definition, Classification and Epidemiology. Curr Heart Fail Rep. 2017 Oct;14(5):385-392. doi: 10.1007/s11897-017-0351-y. Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005. O'Connor CM, Abraham WT, Albert NM, Clare R, Gattis Stough W, Gheorghiade M, Greenberg BH, Yancy CW, Young JB, Fonarow GC. Predictors of mortality after discharge in patients hospitalized with heart failure: an analysis from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2008 Oct;156(4):662-73. doi: 10.1016/j.ahj.2008.04.030. Cleland JG, Swedberg K, Follath F, Komajda M, Cohen-Solal A, Aguilar JC, Dietz R, Gavazzi A, Hobbs R, Korewicki J, Madeira HC, Moiseyev VS, Preda I, van Gilst WH, Widimsky J, Freemantle N, Eastaugh J, Mason J; Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. The EuroHeart Failure survey programme-- a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. Eur Heart J. 2003 Mar;24(5):442-63. doi: 10.1016/s0195-668x(02)00823-0. Komajda M, Follath F, Swedberg K, Cleland J, Aguilar JC, Cohen-Solal A, Dietz R, Gavazzi A, Van Gilst WH, Hobbs R, Korewicki J, Madeira HC, Moiseyev VS, Preda I, Widimsky J, Freemantle N, Eastaugh J, Mason J; Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. The EuroHeart Failure Survey programme--a survey on the quality of care among patients with heart failure in Europe. Part 2: treatment. Eur Heart J. 2003 Mar;24(5):464-74. doi: 10.1016/s0195-668x(02)00700-5. Maggioni AP, Dahlstrom U, Filippatos G, Chioncel O, Crespo Leiro M, Drozdz J, Fruhwald F, Gullestad L, Logeart D, Fabbri G, Urso R, Metra M, Parissis J, Persson H, Ponikowski P, Rauchhaus M, Voors AA, Nielsen OW, Zannad F, Tavazzi L; Heart Failure Association of the European Society of Cardiology (HFA). EURObservational Research Programme: regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF Pilot). Eur J Heart Fail. 2013 Jul;15(7):808-17. doi: 10.1093/eurjhf/hft050. Epub 2013 Mar 28. Follath F, Yilmaz MB, Delgado JF, Parissis JT, Porcher R, Gayat E, Burrows N, McLean A, Vilas-Boas F, Mebazaa A. Clinical presentation, management and outcomes in the Acute Heart Failure Global Survey of Standard Treatment (ALARM-HF). Intensive Care Med. 2011 Apr;37(4):619-26. doi: 10.1007/s00134-010-2113-0. Epub 2011 Jan 6. Suzuki S, Yoshihisa A, Sato Y, Kanno Y, Watanabe S, Abe S, Sato T, Oikawa M, Kobayashi A, Yamaki T, Kunii H, Nakazato K, Ishida T, Takeishi Y. Clinical Significance of Get With the Guidelines-Heart Failure Risk Score in Patients With Chronic Heart Failure After Hospitalization. J Am Heart Assoc. 2018 Sep 4;7(17):e008316. doi: 10.1161/JAHA.117.008316. 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. Magnussen C, Blankenberg S. Biomarkers for heart failure: small molecules with high clinical relevance. J Intern Med. 2018 Jun;283(6):530-543. doi: 10.1111/joim.12756. Epub 2018 Apr 22. Soares FLJ, Oliveira JMG, Freire GNDC, Andrade LC, Noya-Rabelo MM, Correia LCL. Incremental Prognostic Value of Conventional Echocardiography in Patients with Acutely Decompensated Heart Failure. Arq Bras Cardiol. 2017 Dec;109(6):560-568. doi: 10.5935/abc.20170173. Epub 2017 Nov 27. 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. Hirata K, Hyodo E, Hozumi T, Kita R, Hirose M, Sakanoue Y, Nishida Y, Kawarabayashi T, Yoshiyama M, Yoshikawa J, Akasaka T. Usefulness of a combination of systolic function by left ventricular ejection fraction and diastolic function by E/E' to predict prognosis in patients with heart failure. Am J Cardiol. 2009 May 1;103(9):1275-9. doi: 10.1016/j.amjcard.2009.01.024. Epub 2009 Mar 9. Wang M, Yip GW, Wang AY, Zhang Y, Ho PY, Tse MK, Lam PK, Sanderson JE. Peak early diastolic mitral annulus velocity by tissue Doppler imaging adds independent and incremental prognostic value. J Am Coll Cardiol. 2003 Mar 5;41(5):820-6. doi: 10.1016/s0735-1097(02)02921-2. Shah RV, Chen-Tournoux AA, Picard MH, van Kimmenade RR, Januzzi JL. Galectin-3, cardiac structure and function, and long-term mortality in patients with acutely decompensated heart failure. Eur J Heart Fail. 2010 Aug;12(8):826-32. doi: 10.1093/eurjhf/hfq091. Epub 2010 Jun 5. Arques S, Roux E, Ambrosi P, Sbragia P, Gelisse R, Pieri B, Luccioni R. Accuracy of bedside tissue Doppler echocardiography for the prediction of in-hospital mortality in elderly patients with acute heart failure with preserved left ventricular systolic function. comparison with B-type natriuretic peptide measurement. Int J Cardiol. 2007 Dec 15;123(1):69-72. doi: 10.1016/j.ijcard.2006.11.094. Epub 2007 Feb 6. Aronson D, Darawsha W, Atamna A, Kaplan M, Makhoul BF, Mutlak D, Lessick J, Carasso S, Reisner S, Agmon Y, Dragu R, Azzam ZS. Pulmonary hypertension, right ventricular function, and clinical outcome in acute decompensated heart failure. J Card Fail. 2013 Oct;19(10):665-71. doi: 10.1016/j.cardfail.2013.08.007. Merlos P, Nunez J, Sanchis J, Minana G, Palau P, Bodi V, Husser O, Santas E, Bondanza L, Chorro FJ. Echocardiographic estimation of pulmonary arterial systolic pressure in acute heart failure. Prognostic implications. Eur J Intern Med. 2013 Sep;24(6):562-7. doi: 10.1016/j.ejim.2013.04.009. Epub 2013 May 15. Carluccio E, Dini FL, Biagioli P, Lauciello R, Simioniuc A, Zuchi C, Alunni G, Reboldi G, Marzilli M, Ambrosio G. The 'Echo Heart Failure Score': an echocardiographic risk prediction score of mortality in systolic heart failure. Eur J Heart Fail. 2013 Aug;15(8):868-76. doi: 10.1093/eurjhf/hft038. Epub 2013 Mar 19. Cameli M, Mondillo S, Galderisi M, Mandoli GE, Ballo P, Nistri S, Capo V, D'Ascenzi F, D'Andrea A, Esposito R, Gallina S, Montisci R, Novo G, Rossi A, Mele D, Agricola E. [Speckle tracking echocardiography: a practical guide]. G Ital Cardiol (Rome). 2017 Apr;18(4):253-269. doi: 10.1714/2683.27469. Italian. Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zaca V, Ballo P, D'Andrea A, Muraru D, Losi M, Agricola E, D'Errico A, Buralli S, Sciomer S, Nistri S, Badano L; Echocardiography Study Group Of The Italian Society Of Cardiology (Rome, Italy). Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med. 2011 Jan;30(1):71-83. doi: 10.7863/jum.2011.30.1.71. Meris A, Faletra F, Conca C, Klersy C, Regoli F, Klimusina J, Penco M, Pasotti E, Pedrazzini GB, Moccetti T, Auricchio A. Timing and magnitude of regional right ventricular function: a speckle tracking-derived strain study of normal subjects and patients with right ventricular dysfunction. J Am Soc Echocardiogr. 2010 Aug;23(8):823-31. doi: 10.1016/j.echo.2010.05.009. Epub 2010 Jun 19. Cameli M, Caputo M, Mondillo S, Ballo P, Palmerini E, Lisi M, Marino E, Galderisi M. Feasibility and reference values of left atrial longitudinal strain imaging by two-dimensional speckle tracking. Cardiovasc Ultrasound. 2009 Feb 8;7:6. doi: 10.1186/1476-7120-7-6. Cho GY, Marwick TH, Kim HS, Kim MK, Hong KS, Oh DJ. Global 2-dimensional strain as a new prognosticator in patients with heart failure. J Am Coll Cardiol. 2009 Aug 11;54(7):618-24. doi: 10.1016/j.jacc.2009.04.061. Park JH, Park JJ, Park JB, Cho GY. Prognostic Value of Biventricular Strain in Risk Stratifying in Patients With Acute Heart Failure. J Am Heart Assoc. 2018 Oct 2;7(19):e009331. doi: 10.1161/JAHA.118.009331. Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6. Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70. doi: 10.1016/j.amjcard.2004.02.012. Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003. Quinones MA, Otto CM, Stoddard M, Waggoner A, Zoghbi WA; Doppler Quantification Task Force of the Nomenclature and Standards Committee of the American Society of Echocardiography. Recommendations for quantification of Doppler echocardiography: a report from the Doppler Quantification Task Force of the Nomenclature and Standards Committee of the American Society of Echocardiography. J Am Soc Echocardiogr. 2002 Feb;15(2):167-84. doi: 10.1067/mje.2002.120202. No abstract available. Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Alexandru Popescu B, Waggoner AD; Houston, Texas; Oslo, Norway; Phoenix, Arizona; Nashville, Tennessee; Hamilton, Ontario, Canada; Uppsala, Sweden; Ghent and Liege, Belgium; Cleveland, Ohio; Novara, Italy; Rochester, Minnesota; Bucharest, Romania; and St. Louis, Missouri. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1321-1360. doi: 10.1093/ehjci/jew082. Epub 2016 Jul 15. No abstract available. Mondillo S, Galderisi M, Ballo P, Marino PN; Study Group of Echocardiography of the Italian Society of Cardiology. Left ventricular systolic longitudinal function: comparison among simple M-mode, pulsed, and M-mode color tissue Doppler of mitral annulus in healthy individuals. J Am Soc Echocardiogr. 2006 Sep;19(9):1085-91. doi: 10.1016/j.echo.2006.04.005. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Matteo Cameli, Prof
Query!
Address
0
0
Department of Medical Biotechnologies Division of Cardiology University of Siena
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05204238