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Active, not recruitingNCT03418467EMPATHYUpdated Mar 28, 2025

Risk Factors in Tachycardiomyopathy

An observational study in Atrial Fibrillation, Atrial Flutter and Ventricular Premature Complexes, sponsored by University Hospital Tuebingen. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by University Hospital Tuebingen · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Atrial Fibrillation
  • Atrial Flutter
  • Ventricular Premature Complexes

Keywords

  • Tachycardiomyopathy
  • atrial fibrillation
  • EMID (enrichment of mitochondria at the intercalated discs)
  • Biopsy
  • empathy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. recurrence of rhythm disturbance

    Evaluating the recurrence of the underlying rhythm disturbance (ECG, 7 day holter monitoring, implantable event recorder)

    Time frame: 3 months

  2. rehospitalization

    Evaluating the rate of unplanned rehospitalization

    Time frame: 3 months

  3. all-cause mortality

    Evaluating the all-cause mortality

    Time frame: 3 months

  4. NYHA class (New York Heart Association)

    Evaluating the extend of heart failure symptoms.

    Time frame: 3 months

06

Study locations

1 site
  • Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)
    Tübingen, 72076, Germany
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03418467
Lead sponsor
University Hospital Tuebingen
Responsible party
Sponsor
First posted
Feb 1, 2018
Start date
Oct 11, 2018
Primary completion
Jan 31, 2025
Completion
May 2030 (estimated)
Last update
Mar 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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