Clinical Trials Directory

Trials / Completed

CompletedNCT02369419

Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

Status
Completed
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERFrailtyCRT 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

Timeline

Start date
2013-01-01
Primary completion
2016-03-01
Completion
2016-03-01
First posted
2015-02-24
Last updated
2016-12-01

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02369419. Inclusion in this directory is not an endorsement.