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NCT Number: NCT03418467

Risk Factors in 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Premature Complexes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. histological characteristics

    Time frame: 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 outcomes

  1. recurrence of rhythm disturbance

    Time frame: 3 months

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

  2. rehospitalization

    Time frame: 3 months

    Evaluating the rate of unplanned rehospitalization

  3. all-cause mortality

    Time frame: 3 months

    Evaluating the all-cause mortality

  4. NYHA class (New York Heart Association)

    Time frame: 3 months

    Evaluating the extend of heart failure symptoms.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Evaluation of Risk Factors for Therapeutic Outcome in Patients with Tachycardiomyopathy

Acronym: EMPATHY

Important dates

Study start
2018
Primary completion
2025
Study completion
2030
First posted
Feb 1, 2018
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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