Risk Factors in Tachycardiomyopathy

N/AActive Not RecruitingNCT03418467

University Hospital Tuebingen60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation Atrial Flutter Ventricular Premature Complexes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

recurrence of rhythm disturbance

Evaluating the recurrence of the underlying rhythm disturbance (ECG, 7 day holter monitoring, implantable event recorder)

Time frame: 3 months

rehospitalization

Evaluating the rate of unplanned rehospitalization

Time frame: 3 months

all-cause mortality

Evaluating the all-cause mortality

Time frame: 3 months

NYHA class (New York Heart Association)

Evaluating the extend of heart failure symptoms.

Time frame: 3 months

Risk Factors in Tachycardiomyopathy

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes