ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors in Tachycardiomyopathy (EMPATHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03418467
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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.


Condition or disease
Atrial Fibrillation Atrial Flutter Ventricular Premature Complexes

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Risk Factors for Therapeutic Outcome in Patients With Tachycardiomyopathy
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418467


Contacts
Contact: Peter Seizer, MD 0049 7071 29 83688 peter.seizer@med.uni-tuebingen.de
Contact: David Heinzmann, MD 0049 7071 29 83688 david.heinzmann@med.uni-tuebingen.de

Locations
Germany
Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie) Recruiting
Tübingen, Germany, 72076
Contact: Peter Seizer, MD    0049 7071 29 83688    peter.seizer@med.uni-tuebingen.de   
Contact: David Heinzmann, MD    0049 7071 29 83688    david.heinzmann@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen

Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03418467     History of Changes
Other Study ID Numbers: EMPATHY-1
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Tuebingen:
Tachycardiomyopathy
atrial fibrillation
EMID (enrichment of mitochondria at the intercalated discs)
Biopsy
empathy

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Ventricular Premature Complexes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Complexes, Premature