- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02441218
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study (SHIFT)
2. januar 2020 opdateret af: Institut de Recherches Internationales Servier
The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6505
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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
Inclusion Criteria:
- Symptomatic Chronic heart failure (NYHA II, III or IV)
- Left ventricular systolic dysfunction (LVEF ≤ 35%)
- Sinus rhythm and resting heart rate ≥ 70 bpm
- Optimal and unchanged CHF medications or dosages
Exclusion Criteria:
- Unstable condition within previous 4 weeks
- Myocardial infarction or coronary revascularisation within previous 2 months
- Stroke or transient cerebral ischaemia within previous 4 weeks
- Congenital heart disease
- Severe valvular disease
- Active myocarditis
- Permanent atrial fibrillation or flutter
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
|
Eksperimentel: Ivabradin
|
2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.
Tidsramme: All over the study (up to 42 months).
|
Number of patients having experienced the Primary Composite Endpoint.
|
All over the study (up to 42 months).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cardiovascular Death
Tidsramme: From the date of randomization until the date of death, up to 42 months
|
Component of the primary composite endpoint
|
From the date of randomization until the date of death, up to 42 months
|
Hospitalisation for Worsening Heart Failure
Tidsramme: From the date of randomization to the date of first documented hospitalisation, up to 42 months
|
From the date of randomization to the date of first documented hospitalisation, up to 42 months
|
|
All-cause Mortality
Tidsramme: From the date of randomisation to death, up to 42 months.
|
From the date of randomisation to death, up to 42 months.
|
|
Death From Heart Failure
Tidsramme: From the date of randomisation to death, up to 42 months.
|
Component of cardiovascular death
|
From the date of randomisation to death, up to 42 months.
|
Hospitalisation for Any Cause
Tidsramme: From the date of randomisation to the date of first documented hospitalisation, up to 42 months
|
From the date of randomisation to the date of first documented hospitalisation, up to 42 months
|
|
Hospitalisation for Cardiovascular Reason
Tidsramme: From the date of randomisation to the first documented hospitalisation, up to 42 months
|
From the date of randomisation to the first documented hospitalisation, up to 42 months
|
|
Unplanned Hospitalisation for Any Cause
Tidsramme: From the date of randomisation to the first documented hospitalisation, up to 42 months
|
From the date of randomisation to the first documented hospitalisation, up to 42 months
|
|
Unplanned Hospitalisation for CV Reason
Tidsramme: From the date of randomisation to the first documented hospitalisation, up to 42 months.
|
From the date of randomisation to the first documented hospitalisation, up to 42 months.
|
|
Secondary Composite Endpoint
Tidsramme: From the date of randomisation to the date of the first event, up to 42 months
|
CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction
|
From the date of randomisation to the date of the first event, up to 42 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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
- Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.1016/S0140-6736(10)61198-1. Erratum In: Lancet. 2010 Dec 11;376(9757):1988. Lajnscak, M [corrected to Lainscak, M]; Rabanedo, I Roldan [corrected to Rabadan, I Roldan]; Leva, M [corrected to Ieva, M].
- Bohm M, Swedberg K, Komajda M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Heart rate as a risk factor in chronic heart failure (SHIFT): the association between heart rate and outcomes in a randomised placebo-controlled trial. Lancet. 2010 Sep 11;376(9744):886-94. doi: 10.1016/S0140-6736(10)61259-7.
- Tyl B, Lopez Sendon J, Borer JS, Lopez De Sa E, Lerebours G, Varin C, De Montigny A, Pannaux M, Komajda M. Comparison of Outcome Adjudication by Investigators and by a Central End Point Committee in Heart Failure Trials: Experience of the SHIFT Heart Failure Study. Circ Heart Fail. 2020 Jul;13(7):e006720. doi: 10.1161/CIRCHEARTFAILURE.119.006720. Epub 2020 Jun 25.
- Griffiths A, Paracha N, Davies A, Branscombe N, Cowie MR, Sculpher M. Analyzing Health-Related Quality of Life Data to Estimate Parameters for Cost-Effectiveness Models: An Example Using Longitudinal EQ-5D Data from the SHIFT Randomized Controlled Trial. Adv Ther. 2017 Mar;34(3):753-764. doi: 10.1007/s12325-016-0471-x. Epub 2017 Feb 15.
Hjælpsomme links
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 2006
Primær færdiggørelse (Faktiske)
1. april 2010
Studieafslutning (Faktiske)
1. april 2010
Datoer for studieregistrering
Først indsendt
5. maj 2015
Først indsendt, der opfyldte QC-kriterier
7. maj 2015
Først opslået (Skøn)
12. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CL3-16257-063
- 2006-000708-18 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).
They can ask all interventional clinical studies:
- submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
- Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
IPD-delingstidsramme
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD-delingsadgangskriterier
Researchers should register on Servier Data Portal and fill in the research proposal form.
This form in four parts should be fully documented.
The Research Proposal Form will not be reviewed until all mandatory fields are completed.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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 Kronisk hjertesvigt
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Region SkaneTilmelding efter invitationHjertesvigt New York Heart Association (NYHA) klasse II | Hjertesvigt New York Heart Association (NYHA) klasse IIISverige
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Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan... og andre samarbejdspartnereIkke rekrutterer endnuHjertesvigt, systolisk | Hjertesvigt med reduceret udstødningsfraktion | Hjertesvigt New York Heart Association Klasse IV | Hjertesvigt New York Heart Association Klasse IIIPolen
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University of WashingtonAmerican Heart AssociationAfsluttetHjertesvigt, Kongestiv | Mitokondriel ændring | Hjertesvigt New York Heart Association Klasse IVForenede Stater
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Novartis PharmaceuticalsAfsluttetPatienter, der med succes afslutter den 12-måneders behandlingsperiode i kernestudiet (de Novo Heart-modtagere), som var interesserede i at blive behandlet med EC-MPS
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NYU Langone HealthRekrutteringTako-tsubo kardiomyopati | Takotsubo kardiomyopati | Broken Heart SyndromeForenede Stater
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Kliniske forsøg med Ivabradine
-
Assistance Publique - Hôpitaux de ParisRekruttering
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University of California, San DiegoAmgenAfsluttetPosturalt ortostatisk takykardisyndromForenede Stater
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Institut de Recherches Internationales ServierAfsluttetKoronar sygdom | Ventrikulær dysfunktion, venstreDet Forenede Kongerige
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Medical University of WarsawUkendt
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Asan Medical CenterInstitut de Recherches Internationales ServierAfsluttetSundt individKorea, Republikken
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Qian gengRekruttering
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Institut de Recherches Internationales ServierAfsluttet
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Tel-Aviv Sourasky Medical CenterUkendtPosturalt takykardisyndrom
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Kanecia Obie ZimmermanTilmelding efter invitationLang COVID | Lang Covid19 | Lang Covid-19Forenede Stater
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St Vincent's University Hospital, IrelandTrukket tilbageDiastolisk hjertesvigtIrland