NEW-CRT: New Echocardiographic Parameters for Prediction of Response to Cardiac Resynchronization Therapy

Sponsor

Heidelberg University (Other)

Overall Status

Terminated

CT.gov ID

NCT02375399

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure

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 Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

NYHA [12 months]
New York Heart Association (NYHA) functional classification
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)
LV EF [12 month]
left ventricular (LV) ejection fraction (EF)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, University of Heidelberg	Heidelberg	BW	Germany	69120

Sponsors and Collaborators

Heidelberg University

Investigators

Principal Investigator: Mathias Konstandin, M.D., Heidelberg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mathias Konstandin, M.D., Heidelberg University

ClinicalTrials.gov Identifier:

NCT02375399

Other Study ID Numbers:

S-553/2012

First Posted:

Mar 2, 2015

Last Update Posted:

Jun 3, 2016

Last Verified:

Jun 1, 2016

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jun 3, 2016