New Echocardiographic Parameters for Prediction of Response to Cardiac Resynchronization Therapy

Congestive Heart Failure Clinical Trial

— NEW-CRT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02375399
• Other study ID #: S-553/2012
• 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

• Congestive Heart Failure
• Heart Failure

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