Congestive Heart Failure Clinical Trial
— NEW-CRTOfficial title:
New Approaches to Echocardiography Assessment of Cardiac Dyssynchrony: Relevance Concerning Response Rate to Cardiac Resynchronization Therapy
Verified date | June 2016 |
Source | Heidelberg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
Echocardiography parameters for cardiac dyssynchrony had no predictive value in current multicentric prospective studies concerning cardiac resynchronization therapy. Comprehensive echocardiography and new parameters as 2D and 3D strain, as well as 3D echo have been analyzed, but their definite value has not been proven yet.
Status | Terminated |
Enrollment | 15 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - congestive heart failure, dilated cardiomyopathy, indication for implantation of a CRT-device according to the European Society of Cardiology (ESC) Exclusion Criteria: - persons who are incapable of giving informed consent - acute heart attack - arrhythmia during the examination (such as atrial fibrillation and frequent VES) - state after STEMI with an extended scar - inotropic drug therapy - pre-existing permanent pacemaker stimulation |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Department of Cardiology, University of Heidelberg | Heidelberg | BW |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3D echocardiography | offline analysis of echocardiography data | 12 months | No |
Primary | 2D strain | offline analysis of echocardiography data | 12 months | No |
Primary | m-mode echocardiography | offline analysis of echocardiography data | 12 months | No |
Secondary | NYHA | New York Heart Association (NYHA) functional classification | 12 months | No |
Secondary | six-min walk test | distance walked over 6 minutes as a sub-maximal test of aerobic capacity | 12 months | No |
Secondary | NT-proBNP | N-terminal prohormone of brain natriuretic peptide (NT-proBNP) | 12 months | No |
Secondary | LV EF | left ventricular (LV) ejection fraction (EF) | 12 month | No |
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