Risk Factors in Tachycardiomyopathy

NCT03418467 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Tuebingen

Phase

Observational

Started

2018-10-11

Last updated

2025-03-28

Condition(s) studied

Atrial FibrillationAtrial FlutterVentricular Premature Complexes

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)	Tübingen	Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03418467 on ClinicalTrials.gov ↗ ← All trials in Germany