Risk Factors in Tachycardiomyopathy

Active, not recruiting

• Conditions: Atrial Fibrillation; Ventricular Premature Complexes; Atrial Flutter

• Registration Number: NCT03418467
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-01
• Study Start: 2018-10-11
• Primary Completion: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
NYHA class (New York Heart Association)	3 months	Evaluating the extend of heart failure symptoms.
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

Trial Locations

Locations (1)

Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie); 🇩🇪 Tübingen, Germany