FREnch Survey on Heart Failure (FRESH)
20. september 2022 opdateret af: French Cardiology Society
Heart failure is the most common heart disease with increasing incidence due to the aging of the population is improving the initial prognosis of various conditions that lead to more or less progressive heart failure.
Heart failure is of great variety of clinical and pathophysiological forms necessitating the creation of quality records to clarify each of these forms.
Many types of cardiomyopathies exist, some of which are infrequent but with specific care.
At the French level, few data exist. In addition, the therapeutic management changes regularly.
New European recommendations (endorsed by the French Society of Cardiology = FSC) were published in May 2012. Many therapeutic approaches are being evaluated. The course of care and how to take non-drug load (network monitoring, rehabilitation ...) have become important issues that have hardly been analyzed by existing records.
This also leads to better define the different forms of this disease, their natural history and methods of management applied in real life. The register of FSC follows the registry of the European Society of Cardiology (ESC)"Heart Failure (HF) Long Term" (CCTIRS No. 11.355bis) with inclusions will be completed in November 2012. This new study aims to generate more accurate data on a number of points and be more representative for a wider selection of patients, the French level.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The recruitment period will be 24 months, with a day of inclusion for each week, which will be included both patients external consultant for chronic heart failure patients hospitalized in the cardiology department, during this day for acute heart failure.
Monitoring will be carried out 12 months during a consultation normally scheduled for this type of pathology with the cardiologist investigator. Patients included in a decompensation will also follow up to 3 months
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2719
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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PARIS Cedex 10, Frankrig, 75475
- Hopital Lariboisiere
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All patients over 18 years with chronic heart failure, and all patients hospitalized for acute heart failure de novo or not.
The diagnosis of heart failure is the responsibility of the cardiologist including patient.
Beskrivelse
Inclusion Criteria:
- patient with chronic HF OR patient hospitalized foor acute HF de novo or not
- patient who accept to participate by signing a informed consent
Exclusion Criteria:
- patient who deny to participate
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Heart Failure
All patients over 18 years with chronic heart failure, and all patients hospitalized for acute heart failure de novo or not.
The diagnosis of heart failure is the responsibility of the cardiologist including patient.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mortality at one-year of follow-up
Tidsramme: 12 months
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Death rate at 12 months of follow-up
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12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Morbidity at one year of follow-up
Tidsramme: 12 months
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Collect Chronic obstructive pulmonary disease (COPD) and diabetes mellitus during one year of follow-up, which frequently are associated with heart failure and impact patient outcomes
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur J Heart Fail. 2008 Oct;10(10):933-89. doi: 10.1016/j.ejheart.2008.08.005. Epub 2008 Sep 16. No abstract available. Erratum In: Eur J Heart Fail. 2009 Jan;11(1):110. Eur J Heart Fail. 2010 Apr;12(4):416. Dosage error in article text.
- Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW; American College of Cardiology Foundation; American Heart Association. 2009 Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the International Society for Heart and Lung Transplantation. J Am Coll Cardiol. 2009 Apr 14;53(15):e1-e90. doi: 10.1016/j.jacc.2008.11.013. No abstract available. Erratum In: J Am Coll Cardiol. 2009 Dec 15;54(25):2464.
- Heart Failure Society of America, Lindenfeld J, Albert NM, Boehmer JP, Collins SP, Ezekowitz JA, Givertz MM, Katz SD, Klapholz M, Moser DK, Rogers JG, Starling RC, Stevenson WG, Tang WH, Teerlink JR, Walsh MN. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2010 Jun;16(6):e1-194. doi: 10.1016/j.cardfail.2010.04.004.
- Gheorghiade M, Zannad F, Sopko G, Klein L, Pina IL, Konstam MA, Massie BM, Roland E, Targum S, Collins SP, Filippatos G, Tavazzi L; International Working Group on Acute Heart Failure Syndromes. Acute heart failure syndromes: current state and framework for future research. Circulation. 2005 Dec 20;112(25):3958-68. doi: 10.1161/CIRCULATIONAHA.105.590091. No abstract available.
- Nieminen MS, Bohm M, Cowie MR, Drexler H, Filippatos GS, Jondeau G, Hasin Y, Lopez-Sendon J, Mebazaa A, Metra M, Rhodes A, Swedberg K, Priori SG, Garcia MA, Blanc JJ, Budaj A, Cowie MR, Dean V, Deckers J, Burgos EF, Lekakis J, Lindahl B, Mazzotta G, Morais J, Oto A, Smiseth OA, Garcia MA, Dickstein K, Albuquerque A, Conthe P, Crespo-Leiro M, Ferrari R, Follath F, Gavazzi A, Janssens U, Komajda M, Morais J, Moreno R, Singer M, Singh S, Tendera M, Thygesen K; ESC Committe for Practice Guideline (CPG). Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Feb;26(4):384-416. doi: 10.1093/eurheartj/ehi044. Epub 2005 Jan 28. No abstract available.
- Tavazzi L, Maggioni AP, Lucci D, Cacciatore G, Ansalone G, Oliva F, Porcu M; Italian survey on Acute Heart Failure Investigators. Nationwide survey on acute heart failure in cardiology ward services in Italy. Eur Heart J. 2006 May;27(10):1207-15. doi: 10.1093/eurheartj/ehi845. Epub 2006 Apr 7.
- Ezekowitz JA, Hernandez AF, Starling RC, Yancy CW, Massie B, Hill JA, Krum H, Diaz R, Ponikowski P, Metra M, Howlett JG, Gennevois D, O'Connor CM, Califf RM, Fonarow GC. Standardizing care for acute decompensated heart failure in a large megatrial: the approach for the Acute Studies of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure (ASCEND-HF). Am Heart J. 2009 Feb;157(2):219-28. doi: 10.1016/j.ahj.2008.10.002. Epub 2008 Nov 28.
- 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.
- Gheorghiade M, Abraham WT, Albert NM, Greenberg BH, O'Connor CM, She L, Stough WG, Yancy CW, Young JB, Fonarow GC; OPTIMIZE-HF Investigators and Coordinators. Systolic blood pressure at admission, clinical characteristics, and outcomes in patients hospitalized with acute heart failure. JAMA. 2006 Nov 8;296(18):2217-26. doi: 10.1001/jama.296.18.2217.
- Metra M, Ponikowski P, Dickstein K, McMurray JJ, Gavazzi A, Bergh CH, Fraser AG, Jaarsma T, Pitsis A, Mohacsi P, Bohm M, Anker S, Dargie H, Brutsaert D, Komajda M; Heart Failure Association of the European Society of Cardiology. Advanced chronic heart failure: A position statement from the Study Group on Advanced Heart Failure of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2007 Jun-Jul;9(6-7):684-94. doi: 10.1016/j.ejheart.2007.04.003. Epub 2007 May 3.
- Albert NM, Fonarow GC, Yancy CW, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride M, Mehra MR, O'Connor CM, Reynolds D, Walsh MN. Influence of dedicated heart failure clinics on delivery of recommended therapies in outpatient cardiology practices: findings from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF). Am Heart J. 2010 Feb;159(2):238-44. doi: 10.1016/j.ahj.2009.11.022.
- Fonarow GC, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Inge PJ, Mehra MR, O'Connor CM, Reynolds D, Walsh MN, Yancy CW. Improving evidence-based care for heart failure in outpatient cardiology practices: primary results of the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF). Circulation. 2010 Aug 10;122(6):585-96. doi: 10.1161/CIRCULATIONAHA.109.934471. Epub 2010 Jul 26.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2014
Primær færdiggørelse (Faktiske)
31. december 2021
Studieafslutning (Faktiske)
31. maj 2022
Datoer for studieregistrering
Først indsendt
27. september 2013
Først indsendt, der opfyldte QC-kriterier
7. oktober 2013
Først opslået (Skøn)
8. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2022
Sidst verificeret
1. september 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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