Risk Factors in Tachycardiomyopathy

Atrial Fibrillation Clinical Trial

— EMPATHY  

Official title:

Evaluation of Risk Factors for Therapeutic Outcome in Patients With Tachycardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03418467
• Other study ID #: EMPATHY-1
• Status: Recruiting
• Start date: October 11, 2018
• Est. completion date: May 2020

Study information

• Verified date: January 2018
• Source: University Hospital Tuebingen
• Contact: Peter Seizer, MD
• Phone: 0049 7071 29 83688
• Email: peter.seizer[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Ventricular Premature Complexes

Locations

Country	Name	City	State
Germany	Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	recurrence of rhythm disturbance	Evaluating the recurrence of the underlying rhythm disturbance (ECG, 7 day holter monitoring, implantable event recorder)	3 months
Secondary	rehospitalization	Evaluating the rate of unplanned rehospitalization	3 months
Secondary	all-cause mortality	Evaluating the all-cause mortality	3 months
Secondary	NYHA class (New York Heart Association)	Evaluating the extend of heart failure symptoms.	3 months