Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

Overview

Background: The cardiac resynchronization therapy (CRT) has been shown to improve symptoms and outcome of patients with congestive heart failure (HF), and depressed left ventricular ejection fraction (LVEF < 35 %). The rate of non-responders to CRT is estimated at 30 %. Yet, the impact of frailty on the response to CRT has not been studied, until now. Purpose : To assess the impact of frailty in the elderly, on the response to CRT.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2016

Detailed Description

Methods : Frailty is evaluated before implant ,and defined as <14/17 points using the ONCODAGE score, in 150 patients of > 70 years age, selected for CRT according to the ESC 2013 guidelines. The response to CRT, estimated at 9 months, is defined as an improvement of at least 5 % of the LVEF and the absence of HF hospitalization or cardiovascular death.

Interventions

  • Other: Frailty
    • CRT device is implanted in all patients selected for the study. Frailty is evaluated before implant and defined as <14/17 points using the ONCODAGE score

Arms, Groups and Cohorts

  • CRT
    • Patients over 70 years age, selected for CRT according to the ESC 2013 guidelines.

Clinical Trial Outcome Measures

Primary Measures

  • non response on CRT
    • Time Frame: 9 months

Secondary Measures

  • seric albumin
    • Time Frame: 9 months
    • To assess the impact of seric albumin on the response to CRT
  • seric gammaglutamyltranferase
    • Time Frame: 9 months
    • To assess the impact of seric gammaglutamyltranferase on the response to CRT
  • mortality
    • Time Frame: 9 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patients of > 70 years age, – Selected for CRT according to the ESC 2013 guidelines Exclusion Criteria:

  • patients included in other clinical trial which can interfere with the results of this one

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire, Amiens
  • Collaborator
    • University Hospital, Lille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maciej KUBALA, Principal Investigator, CHU Amiens

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