New Echocardiographic Parameters for Prediction of Response to Cardiac Resynchronization Therapy

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02375399

Acronym

NEW-CRT

Enrollment

Registered

2015-03-02

Start date

2015-03-31

Completion date

2015-09-30

Last updated

2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
3D echocardiography	12 months	offline analysis of echocardiography data
2D strain	12 months	offline analysis of echocardiography data
m-mode echocardiography	12 months	offline analysis of echocardiography data

Secondary

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

Countries

Germany

Outcome results