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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