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Completed

NCT Number: NCT02369419

Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Frailty Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU; Service de Cardiologie, Rythmologie et Stimulation cardiaque

Amiens, 80000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frailty

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

Primary outcomes

  1. non response on CRT

    Time frame: 9 months

Secondary outcomes

  1. seric albumin

    Time frame: 9 months

    To assess the impact of seric albumin on the response to CRT

  2. seric gammaglutamyltranferase

    Time frame: 9 months

    To assess the impact of seric gammaglutamyltranferase on the response to CRT

  3. mortality

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

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

Registry information

Acronym: FRAILTY

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 24, 2015
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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