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NCT03418467Active, not recruiting

Risk Factors in Tachycardiomyopathy

Evaluation of Risk Factors for Therapeutic Outcome in Patients with Tachycardiomyopathy

Source: ClinicalTrials.gov · Last updated 28 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
24 Jan 2018
Start date
11 Oct 2018
Primary completion date
31 Jan 2025
Lead sponsor
University Hospital Tuebingen
NCT number
NCT03418467

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 11 Oct 2018 to the primary completion date, 31 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • simultaneous contraindications against amiodarone treatment and pulmonary vein isolation/ablation therapy
  • present or suspected alcohol/drug dependency will result in exclusion from the study

Other illness

  • relevant valvular disease

Age

  • age \<18 years

Other

  • patient unable or unwilling to give informed consent
  • coronary artery stenosis \>50%

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)
Coordinator of this site? Confirm its status
TübingenGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.