Strain Imaging in Patients With Functional Mitral Regurgitation, Treated With MitraClip
Association of Global Longitudinal Strain and Global Constructive Work With Cardiac Performance and Clinical Outcome One Year After MitraClip Implantation in Functional Mitral Regurgitation
1 other identifier
observational
100
1 country
1
Brief 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 echocardiographic predictors of clinical response and reverse left ventricular remodeling at one-year follow up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2019
CompletedFirst Submitted
Initial submission to the registry
December 30, 2019
CompletedFirst Posted
Study publicly available on registry
January 6, 2020
CompletedJanuary 6, 2020
January 1, 2020
9 months
December 30, 2019
January 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes of LV volumes
change of left ventricular end-diastolic and end-systolic volumes during one-year follow up of the patients
one year
Changes of NYHA class status
measurement of NYHA class status at baseline and one-year follow uo
one year
Secondary Outcomes (1)
Changes of myocardial work of the LV
one year
Study Arms (2)
Device group
patients with heart failure and concomitant severe functional mitral regurgitation that were treated with MitraClip
Control group
patients with heart failure and concomitant severe functional mitral regurgitation that were treated with optimal medical treatment
Interventions
analysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination
Eligibility Criteria
heart failure patients with severe functional mitral regurgitation that are treated either with MitraClip or with optimal medical treatment
You may qualify if:
- patients with EF more than 15% and below 45%
- Heart failure symptoms with NYHA class \>2
- Moderate-to-severe and severe functional Mitral regurgitation
You may not qualify if:
- degenerative mitral regurgitation
- asymptomatic patients
- NYHA class IV patients not able to perform 6MWT
- EF\>45%
- poor echocardiographic acoustic window patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Attikon University Hospital of Athens
Athens, Greece
Related Publications (1)
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.
PMID: 32432839DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ignatios Ikonomidis, Professor
Attikon University Hospital of Athens
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
December 30, 2019
First Posted
January 6, 2020
Study Start
May 10, 2018
Primary Completion
February 10, 2019
Study Completion
May 10, 2019
Last Updated
January 6, 2020
Record last verified: 2020-01