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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02375399
Other study ID # S-553/2012
Secondary ID
Status Terminated
Phase N/A
First received February 24, 2015
Last updated June 2, 2016
Start date March 2015
Est. completion date September 2015

Study information

Verified date June 2016
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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.


Description:

In patients with severe heart failure, delays in the conduction system can result in asynchronous contraction impairing cardiac function. By implantation of pacemaker systems with three leads located in atrium, right ventricle and coronary sinus, tracing back this deranged contraction closer to the physiological excitation propagation is aimed (cardial resynchronization therapy [CRT]). Despite patient selection according to the guidelines nearly one-third of the patients do not profit, neither clinically nor echocardiographically, from an implanted CRT-device. In addition, recent studies have shown that no reliable prediction may be achieved with the known echocardiographic parameters of dyssynchrony, regarding the response to such therapy. The aim of this study is therefore to assess new echocardiographic parameters, which may allow to better predict CRT response.


Recruitment information / eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Cardiology, University of Heidelberg Heidelberg BW

Sponsors (1)

Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

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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