Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy (FRAILTY)

November 30, 2016 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • CHU; Service de Cardiologie, Rythmologie et Stimulation cardiaque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients of > 70 years age, selected for CRT according to the ESC 2013 guidelines

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CRT
Patients over 70 years age, selected for CRT according to the ESC 2013 guidelines.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
non response on CRT
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seric albumin
Time Frame: 9 months
To assess the impact of seric albumin on the response to CRT
9 months
seric gammaglutamyltranferase
Time Frame: 9 months
To assess the impact of seric gammaglutamyltranferase on the response to CRT
9 months
mortality
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

University Hospital, Rouen
University Hospital, Caen
University Hospital, Lille

Investigators

  • Principal Investigator: Maciej KUBALA, CHU Amiens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI2013-02-DR-KUBALA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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