Primary Prevention of Sudden Cardiac Death (PREV-DEATH)

Chronic Heart Failure Clinical Trial

— PREV-DEATH  

Official title:

Primary Prevention of Sudden Cardiac Death in Real Life: Differences With the Pivotal Studies and Their Consequences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894580
• Other study ID #: 2015-04Obs-CHRMT
• Status: Completed
• Phase: N/A
• First received: August 26, 2016
• Last updated: September 5, 2016
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

The efficacy of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden cardiac death (SCD) is well demonstrated but pivotal studies have been published more than 10 years ago and implantation's conditions tend to change.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Heart Failure
• Death
• Death, Sudden, Cardiac
• Heart Failure

Locations

Country	Name	City	State
France	CHR Metz-Thionville	Metz Cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality from any cause		up to 1 year	No