NCT02369419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

3.2 years

First QC Date

February 16, 2015

Last Update Submit

November 30, 2016

Conditions

Heart Failure

Keywords

frailtyHeart failurecardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

  • non response on CRT

    9 months

Secondary Outcomes (3)

  • seric albumin

    9 months

  • seric gammaglutamyltranferase

    9 months

  • mortality

    9 months

Study Arms (1)

CRT

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

Other: Frailty

Interventions

FrailtyOTHER

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

CRT

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients of \> 70 years age,
  • Selected for CRT according to the ESC 2013 guidelines

You may not qualify if:

  • patients included in other clinical trial which can interfere with the results of this one

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU; Service de Cardiologie, Rythmologie et Stimulation cardiaque

Amiens, 80000, France

Location

Related Publications (1)

  • 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.

    PMID: 29759834DERIVED

MeSH Terms

Conditions

Heart FailureFrailty

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maciej KUBALA

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

February 24, 2015

Study Start

January 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

FR(1)