New Echocardiographic Parameters for Prediction of Response to Cardiac Resynchronization Therapy

Terminated

• Conditions: Congestive Heart Failure

• Registration Number: NCT02375399
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-24
• Study Start: 2015-03
• Study First Posted: 2015-03-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2D strain	12 months	offline analysis of echocardiography data
3D echocardiography	12 months	offline analysis of echocardiography data
m-mode echocardiography	12 months	offline analysis of echocardiography data

Secondary Outcome Measures

Name	Time	Method
six-min walk test	12 months	distance walked over 6 minutes as a sub-maximal test of aerobic capacity
LV EF	12 month	left ventricular (LV) ejection fraction (EF)
NYHA	12 months	New York Heart Association (NYHA) functional classification
NT-proBNP	12 months	N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

Trial Locations

Locations (1)

Department of Cardiology, University of Heidelberg; 🇩🇪 Heidelberg, BW, Germany