- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369419
Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy (FRAILTY)
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
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Amiens, France, 80000
- CHU; Service de Cardiologie, Rythmologie et Stimulation cardiaque
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
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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
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To assess the impact of seric gammaglutamyltranferase on the response to CRT
|
9 months
|
mortality
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maciej KUBALA, CHU Amiens
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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