Primary Prevention of Sudden Cardiac Death (PREV-DEATH) (PREV-DEATH)
Primary Prevention of Sudden Cardiac Death in Real Life: Differences With the Pivotal Studies and Their Consequences
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The clinical efficacy of implantable cardioverter defibrillator (ICD) as method of primary prevention of sudden cardiac death (SCD) is well demonstrated today. Unfortunately, selection criteria of patients deemed at risk lacks of specificity. For asymptomatic patients with a left ventricular dysfunction (LVEF), current guidelines support implantation of ICD if the LVEF is ≤35%. This target population corresponds to the one studied in the Sudden Cardiac Death in HEart Failure Trial (SCD-HeFT). This trial is 10 years old. The proportion of patients with LVEF > 30% was low (17%) and the analysis of this subgroup showed no decrease in mortality (hazard ratio = 1.08 [0.57-2.07]). That is why the usefulness of ICD in this segment of the population remains a subject of controversy. Moreover, SCD-HeFT did not offer resynchronization therapy despite the fact that more than 40% of patients included had a QRS signal duration ≥120ms.
Conditions for implantation have since changed considerably. The "routine" nature of the implantation procedure and the desire to maximize patient's protection leads us to address for an implantation more easily. As for the resynchronization, it must be attempted in patients with severe heart failure, LVEF ≤35% and QRS sufficiently prolonged.
This suggests that the implanted population is very different nowadays from those from the pivotal studies in terms of mean LVEF and implanted material. However, these two factors are significantly correlated with the risk of SCD... Therefore, the analysis was done on samples of patients who received ICD in primary prevention setting. This study focused on the effect of resynchronization and LVEF at implantation and the subsequent outcome. The results were broadly compared with those of SCD-HeFT.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Metz Cedex 03, Frankrig, 57085
- CHR Metz-Thionville
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- primo-implantation and primary prevention in New York Heart Association (NYHA) II or III chronic heart failure due to ischemic or non ischemic causes and LVEF ≤35%
Exclusion Criteria:
- Cardiomyopathy other than dilated cardiomyopathy such as hypertrophic cardiomyopathy, congenital or valvular heart disease
- Patients with NYHA class I and IV heart failure
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Mortality from any cause
Tidsramme: up to 1 year
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up to 1 year
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Michel BOUSIER, MD, CHR Metz-Thionville
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015-04Obs-CHRMT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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