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Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

NCT ID: NCT02369419

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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

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Heart Failure

Keywords

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frailty Heart failure cardiac resynchronization therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CRT

Patients over 70 years age, selected for CRT according to the ESC 2013 guidelines.

Frailty

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maciej KUBALA

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU; Service de Cardiologie, Rythmologie et Stimulation cardiaque

Amiens, , France

Site Status

Countries

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France

References

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Kubala M, Guedon-Moreau L, Anselme F, Klug D, Bertaina G, Traulle S, Buiciuc O, Savoure A, Diouf M, Hermida JS. Utility of Frailty Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1523-1533. doi: 10.1016/j.jacep.2017.06.012. Epub 2017 Sep 13.

Reference Type DERIVED
PMID: 29759834 (View on PubMed)

Other Identifiers

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RNI2013-02-DR-KUBALA

Identifier Type: -

Identifier Source: org_study_id