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Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02369419
Acronym
FRAILTY
Enrollment
150
Registered
2015-02-24
Start date
2013-01-31
Completion date
2016-03-31
Last updated
2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

frailty, Heart failure, cardiac resynchronization therapy

Brief 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.

Interventions

OTHERFrailty

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

Sponsors

University Hospital, Lille
CollaboratorOTHER
University Hospital, Rouen
CollaboratorOTHER
University Hospital, Caen
CollaboratorOTHER
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
non response on CRT9 months

Secondary

MeasureTime frameDescription
seric albumin9 monthsTo assess the impact of seric albumin on the response to CRT
seric gammaglutamyltranferase9 monthsTo assess the impact of seric gammaglutamyltranferase on the response to CRT
mortality9 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026