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

June 2, 2016 updated by: Mathias Konstandin, Heidelberg University

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- BW
  - Heidelberg, BW, Germany, 69120
    - Department of Cardiology, University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients referred to the University Hospital of Heidelberg with congestive heart failure to undergo the implantation of CRT device

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)