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Decision between rate control and rhythm control can be a challenge in clinical practice. While there is some guiding evidence, we still lack a comprehensive insight into different subgroups of patients that will benefit from a rhythm control treatment.
EMPATHY is a prospective clinical study in patients presenting with heart failure and a tachyarrhythmic rhythm disturbance. Biomarkers, routinely obtained results from clinical examinations, and results from endomyocardial biopsies shall be evaluated to identify patients which have better outcome from a rhythm control strategy by ablation therapy or, if contraindicated by pharmacological rhythm control.
This study is designed to identifying risk factors and subgroups profiting from rhythm restoration and therefore improve current therapeutic approaches and the rate of recurrence-free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tachycardiomyopathy | Sustained heart rate of over 100 bpm, exclusion of other causes of congestive heart failure including significant valvular disease and coronary artery stenosis over 50%, and partial or complete recovery of left ventricular function after restoration of sinus rhythm or rate control and characteristic histological findings. | ||
| dilated cardiomyopathy | Patients with dilated cardiomyopathy according to the 2016 ESC (European Heart Association) Guidelines for the diagnosis and treatment of acute and chronic heart failure. |
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| Measure | Description | Time Frame |
|---|---|---|
| histological characteristics | Identification of histopathological criteria, which indicate better outcome after rhythm control. Recovery of left ventricular ejection fraction (assessed by echocardiography) will be measured. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence of rhythm disturbance | Evaluating the recurrence of the underlying rhythm disturbance (ECG, 7 day holter monitoring, implantable event recorder) | 3 months |
| rehospitalization | Evaluating the rate of unplanned rehospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting at the University Hospital Tübingen with decreased left ventricular ejection fraction.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie) | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 3 months |
| all-cause mortality | Evaluating the all-cause mortality | 3 months |
| NYHA class (New York Heart Association) | Evaluating the extend of heart failure symptoms. | 3 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005117 | Cardiac Complexes, Premature |
| D000075224 | Cardiac Conduction System Disease |