Risk Factors in Tachycardiomyopathy (EMPATHY)

Evaluation of Risk Factors for Therapeutic Outcome in Patients With Tachycardiomyopathy

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Peter Seizer, MD; Phone Number: 0049 7071 29 83688; Email: peter.seizer@med.uni-tuebingen.de
• Study Contact Backup: Name: David Heinzmann, MD; Phone Number: 0049 7071 29 83688; Email: david.heinzmann@med.uni-tuebingen.de

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)
    • Contact: Peter Seizer, MD; Phone Number: 0049 7071 29 83688; Email: peter.seizer@med.uni-tuebingen.de
    • Contact: David Heinzmann, MD; Phone Number: 0049 7071 29 83688; Email: david.heinzmann@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at the University Hospital Tübingen with decreased left ventricular ejection fraction.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Anticipated): October 11, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: atrial fibrillation; Biopsy; empathy; Tachycardiomyopathy; EMID (enrichment of mitochondria at the intercalated discs)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Cardiac Complexes, Premature; Atrial Fibrillation; Atrial Flutter; Ventricular Premature Complexes
• Other Study ID Numbers: EMPATHY-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No