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
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|
|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|
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.
Patients with dilated cardiomyopathy according to the 2016 ESC (European Heart Association) Guidelines for the diagnosis and treatment of acute and chronic heart failure.
- 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.
- recurrence of rhythm disturbance [ Time Frame: 3 months ]Evaluating the recurrence of the underlying rhythm disturbance (ECG, 7 day holter monitoring, implantable event recorder)
- rehospitalization [ Time Frame: 3 months ]Evaluating the rate of unplanned rehospitalization
- all-cause mortality [ Time Frame: 3 months ]Evaluating the all-cause mortality
- NYHA class (New York Heart Association) [ Time Frame: 3 months ]Evaluating the extend of heart failure symptoms.
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
|Contact: Peter Seizer, MD||0049 7071 29 firstname.lastname@example.org|
|Contact: David Heinzmann, MD||0049 7071 29 email@example.com|
|Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Peter Seizer, MD 0049 7071 29 83688 firstname.lastname@example.org|
|Contact: David Heinzmann, MD 0049 7071 29 83688 email@example.com|