Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Evaluering af intravenøs Levosimendan-effekt på kort sigt behandling af dekompenseret kronisk hjertesvigt.

14. december 2006 opdateret af: Abbott

Randomiseret, multicenter-evaluering af intravenøs Levosimendan-effektivitet versus placebo på kort sigt Behandling af dekompenseret kronisk hjertesvigt: REVIVE II-undersøgelsen.

Formålet med denne undersøgelse er at evaluere effektiviteten af ​​en 24-timers infusion af levosimendan sammenlignet med placebo i behandlingen af ​​dekompenseret kronisk hjertesvigt.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

600

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australien, 2605
        • Canberra Hospital/Cardiology Department
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Royal Prince Alfred Hospital/Department of Cardiology
      • Concord, New South Wales, Australien, NSW 2139
        • Concord Hospital - Heart Failure Clinic/Department of Cardiology
      • Gosford, New South Wales, Australien
        • Gosford Hospital
      • Liverpool, New South Wales, Australien, 2116
        • Liverpool Hospital - Cardiology Research
      • Randwick, New South Wales, Australien
        • Prince of Wales Hospital
      • St. Leonards, New South Wales, Australien
        • Royal North Shore Hospital - Cardiology Department
      • Sydney, New South Wales, Australien
        • St. George Hospital/Cardiology Department
    • Queensland
      • Herston, Queensland, Australien, QLD 4029
        • Royal Brisbane Hospital - Cardiology Department
      • Woolloongabba, Queensland, Australien, 4102
        • The Princess Alexandra Hospital
    • South Australia
      • Bedford Park, South Australia, Australien
        • Flinders Medical Centre - Cardiac Research Department
      • Woodville, South Australia, Australien, 5011
        • Queen Elizabeth Hospital/Cardiology Department
    • Tasmania
      • Hobart, Tasmania, Australien, 7000
        • Royal Hobart Hospital
      • Launceston, Tasmania, Australien, 7250
        • Launceston General Hospital/Cardiac Research Unit
    • Victoria
      • Box Hill, Victoria, Australien
        • Box Hill Hospital - Coronary Care Unit
      • Fitzroy, Victoria, Australien
        • St. Vincent's Hospital - Cardiology Investigational Unit
      • Geelong, Victoria, Australien, 3220
        • Karinia House/Geelong Hospital
      • Parkville, Victoria, Australien, 3050
        • Level 2, Cardiology Department/Royal Melbourne Hospital
    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
        • Heart Research Institute/Sir Charles Gairdner Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Calgary, Alberta, Canada, T2V 1P9
        • Rockyview Hospital, Heart Health Institute
      • Edmonton, Alberta, Canada, T6G 2R7
        • University of Alberta Hospitals
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Health Institute
      • Sudbury, Ontario, Canada, P3E 6B4
        • Neureka Research, Willet Green Niller Centre
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Center Hospital University of Sherbrooke
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 3R2
        • University of Saskatchewan
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University Alabama at Birmingham
      • Birmingham, Alabama, Forenede Stater, 35209
        • Cardiovascular Associates/Office of Clinical Research
      • Birmingham, Alabama, Forenede Stater, 35211
        • Cardiology, P.C. Research
      • Huntsville, Alabama, Forenede Stater, 35801
        • Oracle Research-The Heart Center
      • Mobile, Alabama, Forenede Stater, 36685
        • Providence Hospital Heart Failure Clinic
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Arizona Heart Institute
      • Tucson, Arizona, Forenede Stater, 85724
        • Sarver Heart Center - University of Arizona Health Science
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Central Arkansas Veterans Healthcare System
    • California
      • Bakersfield, California, Forenede Stater, 93301
        • Central Cardiology Medical Center
      • Beverly Hills, California, Forenede Stater, 90210
        • Cardiovascular Medical Group & Research Institute
      • Encinitas, California, Forenede Stater, 92024
        • San Diego Cardiovascular Research
      • Inglewood, California, Forenede Stater, 90301
        • Apex Cardiology Consultants, Inc.
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Forenede Stater, 90073
        • VA Greater Los Angeles Healthcare System
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles County/USC Medical Center
      • Merced, California, Forenede Stater, 95340
        • Merced Heart Associates
      • Redondo Beach, California, Forenede Stater, 90277
        • A.R.I. Clinical Trials, Inc.
      • Sacramento, California, Forenede Stater, 95825
        • Sacramento Heart and Vascular Research Center
      • San Diego, California, Forenede Stater, 92123
        • San Diego Cardiac Center
      • San Diego, California, Forenede Stater, 92161
        • VA San Diego Healthcare System
      • San Diego, California, Forenede Stater, 92103
        • UCSD Medical Center, University of California
      • San Francisco, California, Forenede Stater, 94121
        • VA Hospital of San Francisco
    • Colorado
      • Denver, Colorado, Forenede Stater, 80204
        • Denver Health Medical Center
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06030
        • University of Connecticut Health Center
      • New Haven, Connecticut, Forenede Stater, 06511
        • Hospital of Saint Raphael
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale University School of Medicine/Heart Failure Center
    • Delaware
      • Newark, Delaware, Forenede Stater, 19718
        • Christiana Care Health System
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • George Washington University
      • Washington, District of Columbia, Forenede Stater, 20010
        • Washington Hospital Center - Cardiac Surgery Department
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • University of Florida
      • Jacksonville, Florida, Forenede Stater, 32207
        • Jacksonville Heart Center PA-Baptist Office
      • Jacksonville, Florida, Forenede Stater, 32250
        • Jacksonville Heart Center,PA
      • Lakeland, Florida, Forenede Stater, 33805
        • Watson Clinic Center for Research
      • Melbourne, Florida, Forenede Stater, 32901
        • MIMA Century Research Associates
      • Miami, Florida, Forenede Stater, 33102
        • Jackson Memorial Hospital
      • Miami, Florida, Forenede Stater, 33156
        • Miami Research & Education Foundation
      • Pensacola, Florida, Forenede Stater, 32514
        • The Ford Research Institute PA/NW Florida Heart Group PA
      • Port Charlotte, Florida, Forenede Stater, 33952
        • Victor Howard M.D., P.A. Heart Research Center
      • St. Petersburg, Florida, Forenede Stater, 33701
        • Heart & Vascular Institute of Florida
      • Tampa, Florida, Forenede Stater, 33609
        • Florida Cardiovascular Institute
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30901
        • Augusta Cardiology Clinic, P.C.
      • Savannah, Georgia, Forenede Stater, 31405
        • Memorial Health University Medical Center Research Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Memorial Hospital/Heart Failure Program
      • Elgin, Illinois, Forenede Stater, 60120
        • Elgin Cardiology Associates
      • Lombard, Illinois, Forenede Stater, 60148
        • Midwest Heart Research Foundation
      • Peoria, Illinois, Forenede Stater, 61603
        • Heart Care Midwest
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Clarian Health - Methodist Research Institute Inc.
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50314
        • Iowa Heart Center
      • Iowa City, Iowa, Forenede Stater, 52242
        • University Hospital, Iowa City
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Research Inc. dba PriVia
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Gill Heart Institute/University of Kentucky
    • Louisiana
      • Chalmette, Louisiana, Forenede Stater, 70043
        • Louisiana Heart Center
      • Covington, Louisiana, Forenede Stater, 70433
        • New Orleans Clinical Trial Management, Inc.
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University Health Sciences Center
      • Shreveport, Louisiana, Forenede Stater, 71135
        • Cardiac Centers of Louisiana, LLC
      • Slidell, Louisiana, Forenede Stater, 70458
        • Medical Research Institute
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • The Johns Hopkins Hospital
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland Hospital
      • Baltimore, Maryland, Forenede Stater, 21224
        • John Hopkins Bayview Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Medical Center, CACR
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University
      • Petoskey, Michigan, Forenede Stater, 49770
        • Nisus Research/Northern Michigan Hospital
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • Michigan Heart P.C.
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55414
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forenede Stater, 55417
        • VA Medical Center - Cardiology Department
      • St. Paul, Minnesota, Forenede Stater, 55102
        • St. Paul Clinic
    • Missouri
      • Columbus, Missouri, Forenede Stater, 65212
        • University Hospitals Clinic
      • St. Louis, Missouri, Forenede Stater, 63110
        • Saint Louis University Hospital
    • Montana
      • Missoula, Montana, Forenede Stater, 59802
        • International Heart Institute Montana Foundation
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68131
        • The Creighton Cardiac Center
      • Omaha, Nebraska, Forenede Stater, 68122
        • Alegent Health Heart and Vascular Institute
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
      • Newark, New Jersey, Forenede Stater, 07112
        • Heart Failure & Transplantation Program
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • Heart Hospital of New Mexico - NW Heart Institute
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Jack D. Weiler Hospital/Albert Einstein Hospital
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center/Cardiology Department
      • New York, New York, Forenede Stater, 10032
        • Columbia-Presbyterian Medical Center
      • New York, New York, Forenede Stater, 10011
        • St. Vincent's Hospital
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Medical Center NY/Phillips Ambulatory Care Center
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • University of Cincinnati Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45219
        • The Lindner Center
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals of Cleveland
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation/Department of Cardiology
      • Columbus, Ohio, Forenede Stater, 43210
        • OSU Medical Center-Center Wellness & Prevention
      • Toledo, Ohio, Forenede Stater, 43623
        • The Toledo Clinic & Outpatient Surgery
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic & Outpatient Surgery/Department of Cardiology
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma Foundation-Cardiovascular
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University Health Science Center/Cardio Section
    • Oregon
      • Hillsboro, Oregon, Forenede Stater, 97123
        • Hillsboro Cardiology, PC
      • Portland, Oregon, Forenede Stater, 97201
        • Oregon Health & Science University
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center/Heart Failure Clinic
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Health System
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • The Milton S. Hershey Medical Center
      • Lancaster, Pennsylvania, Forenede Stater, 17603
        • Heart Group
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Jefferson Heart Institute
      • Philadelphia, Pennsylvania, Forenede Stater, 19102
        • Hahnemann University Hospital/HF and Transplant Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Universtiy of PA Health System
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh
      • Sellersville, Pennsylvania, Forenede Stater, 18960
        • Buxmont Cardiology Associates
      • West Reading, Pennsylvania, Forenede Stater, 19611
        • Cardiology Associates of West Reading
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02905
        • Rhode Island Hospital/University Cardiology
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
        • Baptist Clinical Research Center
      • Tullahoma, Tennessee, Forenede Stater, 37388
        • Cardiology Group, P.C.
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Austin-Cardiovascular Associates
      • Dallas, Texas, Forenede Stater, 75216
        • Dallas VA Medical Center
      • Dallas, Texas, Forenede Stater, 75231
        • Cardiovascular Research Institute of Dallas
      • Dallas, Texas, Forenede Stater, 75230
        • Cardiopulmonary Research Science & Technology Institute
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forenede Stater, 77030
        • Houston VA Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • St. Luke's Episcopal Hospital/Texas Heart Institute
      • Nassau Bay, Texas, Forenede Stater, 77058
        • Heart Specialists
      • San Antonio, Texas, Forenede Stater, 78229
        • University of Texas Health Sciences
      • Tyler, Texas, Forenede Stater, 75708
        • UTHCT/Center for Clinical Research
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Sentara Norfolk General Hospital
      • Roanoke, Virginia, Forenede Stater, 24011
        • Carilion Department of Clinical Research
      • South Boston, Virginia, Forenede Stater, 24592
        • DUCCS Research of South Boston
    • Washington
      • Bellevue, Washington, Forenede Stater, 98004
        • Overlake Hospital Medical Center
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington
      • Spokane, Washington, Forenede Stater, 99204
        • Inland Cardiology Associates
      • Vancouver, Washington, Forenede Stater, 98664
        • Southwest Washington Medical Center
    • Wisconsin
      • Beloit, Wisconsin, Forenede Stater, 53511
        • Beloit Clinic, SC
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • St. Luke's Medical Center
  • Israel
      • Ashkelon, Israel, 78306
        • Barzilai Medical Center
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center
      • Holon, Israel, 58100
        • Wolfson Medical Center
      • Jerusalem, Israel, 91120
        • Heart Institute, Hadassah MC
      • Nazareth, Israel, 16100
        • EMMS Nazareth Hospital
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Zefat, Israel, 13100
        • Sieff Medical Center
      • Zrifin, Israel, 70300
        • Assaf Harofe Medical Center

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

Beskrivelse

Inklusionskriterier:

  • Der skal indhentes skriftligt informeret samtykke for indlagte mandlige eller kvindelige patienter over 18 år.
  • De berettigede patienter skal diagnosticeres med forværret hjerteinsufficiens, hvilket fremgår af dyspnø i hvile, dårlig ejektionsfraktion og er blevet behandlet med IV diuretika.
  • Det er tilladt for patienterne at blive behandlet med IV inotrope og vasodilatorer.

Ekskluderingskriterier:

Følgende kriterier vil udelukke patienten fra undersøgelsen:

  • invasiv hjerteprocedure (f. hjertekirurgi, LVAD, kardioversion, resynkronisering af hjertet),
  • rytmeforstyrrelser (fx tidligere Torsades de Pointes, øget hjertefrekvens),
  • alvorlig ventrikulær udstrømningsobstruktion,
  • angina,
  • hypotension,
  • ukorrigeret hypokaliæmi,
  • CNS (fx slagtilfælde, TIA),
  • luftvejene (f. KOL, intuberede patienter, orale,
  • intravenøse eller intramuskulære steroider),
  • nyreinsufficiens (f. øget serumkreatinin, dialyse),
  • nedsat leverfunktion (f. signifikant stigning i leverenzymer),
  • dekompensation fra aktiv infektion og akut blødning (f. svær anæmi).
  • Kvindelige patienter i den fødedygtige alder skal have en negativ graviditetstest og anvende passende præventionsforanstaltninger.
  • Også udelukket er brugen af ​​amrinon og milrinon før randomisering, en historie med overfølsomhed over for levosimendan eller et eller flere af hjælpestofferne og tidligere deltagelse i et klinisk forsøg med enhver eksperimentel behandling inden for de sidste 30 dage.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
En klinisk sammensat klassifikation, der inkorporerer en global patientvurdering efter 6 timer, 24 timer og dag 5, kombineret med kliniske kriterier for forværring af hjertesvigt gennem 5 dage efter påbegyndelsen af ​​studiets lægemiddelinfusion.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott

Samarbejdspartnere

Orion Corporation, Orion Pharma

Efterforskere

  • Studieleder: Scott Krause, Abbott

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

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

1. september 2002

Studieafslutning

1. december 2004

Datoer for studieregistrering

Først indsendt

31. oktober 2002

Først indsendt, der opfyldte QC-kriterier

1. november 2002

Først opslået (Skøn)

4. november 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. december 2006

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2006

Sidst verificeret

1. december 2006

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3001069

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 .

Kliniske forsøg med Hjertesvigt, kongestiv

Kliniske forsøg med Levosimendan

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mauritania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner