This trial has been completed.

Condition heart failure
Treatment frailty
Sponsor Centre Hospitalier Universitaire, Amiens
Collaborator University Hospital, Lille
Start date January 2013
End date March 2016
Trial size 150 participants
Trial identifier NCT02369419, RNI2013-02-DR-KUBALA


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients over 70 years age, selected for CRT according to the ESC 2013 guidelines.
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

Primary Outcomes

non response on CRT
time frame: 9 months

Secondary Outcomes

seric albumin
time frame: 9 months
seric gammaglutamyltranferase
time frame: 9 months
time frame: 9 months

Eligibility Criteria

Male or female participants at least 70 years old.

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

Additional Information

Official title Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy
Principal investigator Maciej KUBALA
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire, Amiens.