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Clinical Trials/NCT02375399
NCT02375399
Terminated
Not Applicable

New Approaches to Echocardiography Assessment of Cardiac Dyssynchrony: Relevance Concerning Response Rate to Cardiac Resynchronization Therapy

Heidelberg University1 site in 1 country15 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congestive Heart Failure
Sponsor
Heidelberg University
Enrollment
15
Locations
1
Primary Endpoint
2D strain
Status
Terminated
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
September 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mathias Konstandin

M.D.

Heidelberg University

Eligibility Criteria

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

Outcomes

Primary Outcomes

2D strain

Time Frame: 12 months

offline analysis of echocardiography data

3D echocardiography

Time Frame: 12 months

offline analysis of echocardiography data

m-mode echocardiography

Time Frame: 12 months

offline analysis of echocardiography data

Secondary Outcomes

  • six-min walk test(12 months)
  • LV EF(12 month)
  • NYHA(12 months)
  • NT-proBNP(12 months)

Study Sites (1)

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