EMPATHY: Risk Factors in Tachycardiomyopathy

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Unknown status

CT.gov ID

NCT03418467

Collaborator

(none)

Enrollment

Location

18.7

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Atrial Flutter Ventricular Premature Complexes

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluation of Risk Factors for Therapeutic Outcome in Patients With Tachycardiomyopathy

Anticipated Study Start Date :

Oct 11, 2018

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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