Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

— FRAILTY  

Official title:

Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369419
• Other study ID #: RNI2013-02-DR-KUBALA
• Status: Completed
• Phase: N/A
• First received: February 16, 2015
• Last updated: November 30, 2016
• Start date: January 2013
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
France	CHU; Service de Cardiologie, Rythmologie et Stimulation cardiaque	Amiens

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	University Hospital, Caen, University Hospital, Lille, University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non response on CRT		9 months	Yes
Secondary	seric albumin	To assess the impact of seric albumin on the response to CRT	9 months	Yes
Secondary	seric gammaglutamyltranferase	To assess the impact of seric gammaglutamyltranferase on the response to CRT	9 months	Yes
Secondary	mortality		9 months	Yes