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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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Several attempts have been made to refine selection criteria for cardiac resynchronisation therapy (CRT) in heart failure patients with reduced ejection fraction (HFrEF). Previously proposed parameters probably do not sufficiently reflect the underlying mechanical dyssynchrony of the left ventricle (LV). Earlier work of our research group suggests that better candidate selection can rely on the direct observation or measurement of this LV mechanical dyssynchrony by means of non-invasive imaging. In this study apical rocking and other non-invasive measures of LV mechanical dyssynchrony will be applied to evaluate regional myocardial workload and metabolism, and determine their predictive value in CRT response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac resynchronisation therapy implantation | Other | Patients with current guideline-based indication for CRT implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac resynchronisation therapy | Device |
| ||
| Echocardiography |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac resynchronisation therapy (CRT) response assessed by echocardiography | Reduction in LVESV ≥15% from baseline | Change of left ventricular end-systolic volume (LVESV) between baseline and 6 months after CRT implantation |
| CRT response assessed by echocardiography | Reduction in LVESV ≥15% from baseline | Change of LVESV between baseline and 12 months after CRT implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Reverse left ventricular remodelling measured as changes in left ventricular volume by echocardiography | Measured as changes in left ventricular volume by echocardiography | Change of remodelling between baseline, 6 and 12 months after CRT implantation |
| Reverse left ventricular remodelling measured as changes in left ventricular ejection fraction by echocardiography |
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Inclusion Criteria
Subject is eligible for CRT implantation according to current European Society of Cardiology guidelines of 2013.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens-Uwe Voigt, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Otto A Smiseth, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium | |||
| Oslo University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31820130 | Derived | Degtiarova G, Claus P, Duchenne J, Cvijic M, Schramm G, Nuyts J, Voigt JU, Gheysens O. Low septal to lateral wall 18F-FDG ratio is highly associated with mechanical dyssynchrony in non-ischemic CRT candidates. EJNMMI Res. 2019 Dec 9;9(1):105. doi: 10.1186/s13550-019-0575-9. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 29, 2023 | |
| Reset | Jan 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 29, 2023 | Jan 5, 2024 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013057 | Spectrum Analysis |
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| Other |
|
| Magnetic Resonance Imaging | Other |
|
| Positron Emission Tomography | Other |
|
Measured as changes in left ventricular ejection fraction by echocardiography |
| Change of remodelling between baseline, 6 and 12 months after CRT implantation |
| New York Heart Association (NYHA) class changes | A decrease of ≥1 NYHA class | Change of NYHA class between baseline, 6 and 12 months after CRT implantation |
| Functional capacity changes assessed by 6-minute walking test | Assessed by 6-minute walking test | Change of functional capacity between baseline and 6 months after CRT implantation |
| Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max) | Assessed by peak oxygen uptake ergospirometry (VO2max) | Change of functional capacity between baseline and 6 months after CRT implantation |
| Quality of Life changes | Change of QoL between baseline, 6 and 12 months after CRT implantation |
| Heart failure related hospital admissions | Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation |
| Death | Death by heart failure, sudden cardiac death and all-cause death | Assessment of possible death at 6 and 12 months after CRT implantation |
| Oslo |
| 0372 |
| Norway |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |