Risk Factors in Tachycardiomyopathy

NCT03418467 | Active Not Recruiting

• 1 other identifier: EMPATHY-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Atrial Flutter; Ventricular Premature Complexes

Keywords

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

Outcome Measures

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.

  3 months

Secondary Outcomes (4)

• recurrence of rhythm disturbance

  3 months

• rehospitalization

  3 months

• all-cause mortality

  3 months

• NYHA class (New York Heart Association)

  3 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cardiac Conduction System Disease

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 1, 2018
• Study Start: October 11, 2018
• Primary Completion: January 31, 2025
• Study Completion (Estimated): May 1, 2030
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)