Mitral RegurgitationNCT04218578
Strain Imaging in Patients With Functional Mitral Regurgitation, Treated With MitraClip
An observational study of Mitral Regurgitation and Heart Failure, run by University of Athens at 1 site in Greece.
Trial summary
The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare these variables with patients treated with optimal medical treatment and ii) to find… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Heart Failure
- What is being tested?
- speckle tracking analysis of transthoracic echocardiogram
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 10 May 2018to 10 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: heart failure patients with severe functional mitral regurgitation that are treated either with MitraClip or with optimal medical treatment
Who may be able to join
- patients with EF more than 15% and below 45%
- Heart failure symptoms with NYHA class >2
- Moderate-to-severe and severe functional Mitral regurgitation
Who cannot join
- degenerative mitral regurgitation
- asymptomatic patients
- NYHA class IV patients not able to perform 6MWT
- EF>45%
- poor echocardiographic acoustic window patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Global Longitudinal Strain and Global Constructive Work With Cardiac Performance and Clinical Outcome One Year After MitraClip Implantation in Functional Mitral Regurgitation
The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare these variables with patients treated with optimal medical treatment and ii) to find echocardiographic predictors of clinical response and reverse left ventricular remodeling at one-year follow up.
Read the detailed description
This study is one of the first in terms of publication. As far as the investigators know there are few papers with small series of patients regarding echocardiographic parameters and strain imaging in patients with functional mitral regurgitation (MR) and MitraClip. As the investigator's goal is to assess the potential impact of the MitraClip on myocardial deformation indexes, at the end of the study a direct comparison of changes of echocardiography markers -at one year follow up- between the control and device group will be performed. The changes in myocardial deformation markers will be associated with the respective changes in Brain-natriuretic peptide (BNP) levels, New York Heart Association (NYHA) class status, 6-minute walking distance (6MWD) and left ventricle (LV) volumes at follow -up. The investigators also aim to identify baseline prognostic echocardiography markers for the prediction of clinical improvement and LV reverse remodeling after successful edge-to-edge repair in functional MR patients during one year follow up. In specific, in this study the investigators will measure the 2-Dimension (2D) strain values of the left ventricle and left atrium (global longitudinal strain-GLS of the LV and Peak Atrial longitudinal strain - PALS of the left atrium) at baseline and at one year follow up, they will appreciate the LV myocardial work and all its components (Global Work Index-GWI, Global Constructed Work-GCW,Global wasted work-GWW and Global Work Efficiency-GWE) of the left ventricle and finally they will evaluate the baseline variables as predictors of reverse LV remodeling defined by reduction of left ventricle end-diastolic and end-systolic volume at one-year follow up.
- Conditions
- Mitral Regurgitation, Heart Failure
- Being tested
- speckle tracking analysis of transthoracic echocardiogram
- Keywords
- MitraClip, Functional mitral regurgitation, Reverse remodeling
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speckle tracking analysis of transthoracic echocardiogramDiagnostic test
analysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination
| Study group | Role | What they receive |
|---|---|---|
| Device group | patients with heart failure and concomitant severe functional mitral regurgitation that were treated with MitraClip Receives: Diagnostic Test: speckle tracking analysis of transthoracic echocardiogram | |
| Control group | patients with heart failure and concomitant severe functional mitral regurgitation that were treated with optimal medical treatment Receives: Diagnostic Test: speckle tracking analysis of transthoracic echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of LV volumes
change of left ventricular end-diastolic and end-systolic volumes during one-year follow up of the patients
Measured: one year
Changes of NYHA class status
measurement of NYHA class status at baseline and one-year follow uo
Measured: one year
Secondary outcomes (1)
Changes of myocardial work of the LV
Evaluation of the components of myocardial work (Global work index, global constructive work, Global wasted Work and Global Work efficiency) at baseline and one-year follow up
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start10 May 2018
- Primary completion10 Feb 2019
- Study completion10 May 2019
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 Mitral RegurgitationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, Professor, Study chair, Attikon University Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218578
- Sponsor's protocol ID
- card,EBD308/10-05-2018
- Status last verified
- Jan 2020
- First submitted
- 30 Dec 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Papadopoulos K, Ikonomidis I, Chrissoheris M, Chalapas A, Kourkoveli P, Parissis J, Spargias K. MitraClip and left ventricular reverse remodelling: a strain imaging study. ESC Heart Fail. 2020 Aug;7(4):1409-1418. doi: 10.1002/ehf2.12750. Epub 2020 May 20.
PubMed 32432839
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Global Longitudinal Strain and Global Constructive Work With Cardiac Performance and Clinical Outcome One Year After MitraClip Implantation in Functional Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT04218578
- Acronym / sponsor ID
- card,EBD308/10-05-2018
- Conditions
- Mitral Regurgitation, Heart Failure
- Keywords
- MitraClip, Functional mitral regurgitation, Reverse remodeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 10 Feb 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 6 Jan 2020 (actual)
- 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.
The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare these variables with patients treated with optimal medical treatment and ii) to find echocardiographic predictors of clinical response and reverse left ventricular remodeling at one-year follow up.
Detailed description
This study is one of the first in terms of publication. As far as the investigators know there are few papers with small series of patients regarding echocardiographic parameters and strain imaging in patients with functional mitral regurgitation (MR) and MitraClip. As the investigator's goal is to assess the potential impact of the MitraClip on myocardial deformation indexes, at the end of the study a direct comparison of changes of echocardiography markers -at one year follow up- between the control and device group will be performed. The changes in myocardial deformation markers will be associated with the respective changes in Brain-natriuretic peptide (BNP) levels, New York Heart Association (NYHA) class status, 6-minute walking distance (6MWD) and left ventricle (LV) volumes at follow -up. The investigators also aim to identify baseline prognostic echocardiography markers for the prediction of clinical improvement and LV reverse remodeling after successful edge-to-edge repair in functional MR patients during one year follow up. In specific, in this study the investigators will measure the 2-Dimension (2D) strain values of the left ventricle and left atrium (global longitudinal strain-GLS of the LV and Peak Atrial longitudinal strain - PALS of the left atrium) at baseline and at one year follow up, they will appreciate the LV myocardial work and all its components (Global Work Index-GWI, Global Constructed Work-GCW,Global wasted work-GWW and Global Work Efficiency-GWE) of the left ventricle and finally they will evaluate the baseline variables as predictors of reverse LV remodeling defined by reduction of left ventricle end-diastolic and end-systolic volume at one-year follow up.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device group | – | Diagnostic Test: speckle tracking analysis of transthoracic echocardiogrampatients with heart failure and concomitant severe functional mitral regurgitation that were treated with MitraClip |
| Control group | – | Diagnostic Test: speckle tracking analysis of transthoracic echocardiogrampatients with heart failure and concomitant severe functional mitral regurgitation that were treated with optimal medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- heart failure patients with severe functional mitral regurgitation that are treated either with MitraClip or with optimal medical treatment
Key inclusion criteria (3 listed)
- patients with EF more than 15% and below 45%
- Heart failure symptoms with NYHA class >2
- Moderate-to-severe and severe functional Mitral regurgitation
Key exclusion criteria (5 listed)
- degenerative mitral regurgitation
- asymptomatic patients
- NYHA class IV patients not able to perform 6MWT
- EF>45%
- poor echocardiographic acoustic window patients
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 |
|---|---|---|
| speckle tracking analysis of transthoracic echocardiogramanalysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination | Diagnostic test | Control group, Device group |
Primary outcome
Changes of LV volumes
Time frame: one year
change of left ventricular end-diastolic and end-systolic volumes during one-year follow up of the patients
Changes of NYHA class status
Time frame: one year
measurement of NYHA class status at baseline and one-year follow uo
1 secondary outcome
Changes of myocardial work of the LV
Time frame: one year
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 6 Jan 2020.
- Derived from this study: PubMed 32432839Papadopoulos K, Ikonomidis I, Chrissoheris M, Chalapas A, Kourkoveli P, Parissis J, Spargias K. MitraClip and left ventricular reverse remodelling: a strain imaging study. ESC Heart Fail. 2020 Aug;7(4):1409-1418. doi: 10.1002/ehf2.12750. Epub 2020 May 20.
- Individual participant dataSharing planned: Undecided
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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.
Ignatios Ikonomidis, Professor study chair
Attikon University Hospital of Athens
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 Mitral Regurgitation and Heart Failure, run by University of Athens at 1 site in Greece.
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 3 inclusion and 5 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 6 Jan 2020. 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 Greece. 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?
Changes of LV volumes (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT04218578, 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 6 Jan 2020.