Heart FailureFRAILTYNCT02369419
Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy
An observational study of Heart Failure, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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 %. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Frailty
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients of > 70 years age, selected for CRT according to the ESC 2013 guidelines
Who may be able to join
- Patients of > 70 years age,
- Selected for CRT according to the ESC 2013 guidelines
Who cannot join
- patients included in other clinical trial which can interfere with the results of this one
Trial locations and contacts
1 site in 1 country.
France1 site
CHU; Service de Cardiologie, Rythmologie et Stimulation cardiaque
Amiens, 80000
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Frailty
- Keywords
- frailty, Heart failure, cardiac resynchronization therapy
- Medical subject headings
- Heart Failure, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| CRT | Patients over 70 years age, selected for CRT according to the ESC 2013 guidelines. Receives: Other: Frailty |
What is being measured
The primary outcome is the main question the study is designed to answer.
non response on CRT
Measured: 9 months
Secondary outcomes (3)
seric albumin
To assess the impact of seric albumin on the response to CRT
Measured: 9 months
seric gammaglutamyltranferase
To assess the impact of seric gammaglutamyltranferase on the response to CRT
Measured: 9 months
mortality
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startJan 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maciej KUBALA, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369419
- Sponsor's protocol ID
- RNI2013-02-DR-KUBALA
- Acronym
- FRAILTY
- Status last verified
- Nov 2016
- First submitted
- 16 Feb 2015
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29759834
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT02369419
- Acronym / sponsor ID
- FRAILTY / RNI2013-02-DR-KUBALA
- Conditions
- Heart Failure
- Keywords
- frailty, Heart failure, cardiac resynchronization therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Rouen, University Hospital, Caen
- Study start
- Jan 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT | – | Other: FrailtyPatients over 70 years age, selected for CRT according to the ESC 2013 guidelines. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients of > 70 years age, selected for CRT according to the ESC 2013 guidelines
Key inclusion criteria (2 listed)
- Patients of > 70 years age,
- Selected for CRT according to the ESC 2013 guidelines
Key exclusion criteria (1 listed)
- patients included in other clinical trial which can interfere with the results of this one
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FrailtyCRT 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 | Other | CRT |
Primary outcome
non response on CRT
Time frame: 9 months
3 secondary outcomes
seric albumin
Time frame: 9 months
seric gammaglutamyltranferase
Time frame: 9 months
mortality
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Derived from this study: PubMed 29759834Kubala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej KUBALA principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non response on CRT (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.