Atrial Fibrillation, Atrial Flutter, Ventricular Premature Complexes
Conditions
Keywords
Tachycardiomyopathy, atrial fibrillation, EMID (enrichment of mitochondria at the intercalated discs), Biopsy, empathy
Brief summary
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.
Interventions
None listed
Sponsors
University Hospital Tuebingen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* newly diagnosed left ventricular ejection fraction ≤ 50% * endomyocardial biopsy available * tachycardic rhythm disturbance with a rhythm control strategy planned for tachycardic atrial fibrillation or flutter (≥100/min) or more than 10000 ventricular premature beats in 24 hours
Exclusion criteria
* age \<18 years * patient unable or unwilling to give informed consent * coronary artery stenosis \>50% * relevant valvular disease * simultaneous contraindications against amiodarone treatment and pulmonary vein isolation/ablation therapy * present or suspected alcohol/drug dependency will result in exclusion from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| histological characteristics | 3 months | Identification of histopathological criteria, which indicate better outcome after rhythm control. Recovery of left ventricular ejection fraction (assessed by echocardiography) will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence of rhythm disturbance | 3 months | Evaluating the recurrence of the underlying rhythm disturbance (ECG, 7 day holter monitoring, implantable event recorder) |
| rehospitalization | 3 months | Evaluating the rate of unplanned rehospitalization |
| all-cause mortality | 3 months | Evaluating the all-cause mortality |
| NYHA class (New York Heart Association) | 3 months | Evaluating the extend of heart failure symptoms. |
Countries
Germany
Outcome results
None listed