Risk Factors in Tachycardiomyopathy (EMPATHY)

University Hospital Tuebingen

Status: Active, not recruiting

Conditions: Atrial Flutter; Atrial Fibrillation; Ventricular Premature Complexes

Study type: Observational

Funder types: Other

Identifiers

NCT03418467

EMPATHY-1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

tachycardiomyopathy

Description:

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

Description:

Patients with dilated cardiomyopathy according to the 2016 ESC (European Heart Association) Guidelines for the diagnosis and treatment of acute and chronic heart failure.