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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02375399
First Posted: March 2, 2015
Last Update Posted: June 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mathias Konstandin, Heidelberg University
  Purpose
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
Congestive Heart Failure

Study Type: Observational
Study Design: 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

Further study details as provided by Mathias Konstandin, Heidelberg University:

Primary Outcome Measures:
  • 3D echocardiography [ Time Frame: 12 months ]
    offline analysis of echocardiography data

  • 2D strain [ Time Frame: 12 months ]
    offline analysis of echocardiography data

  • m-mode echocardiography [ Time Frame: 12 months ]
    offline analysis of echocardiography data


Secondary Outcome Measures:
  • NYHA [ Time Frame: 12 months ]
    New York Heart Association (NYHA) functional classification

  • six-min walk test [ Time Frame: 12 months ]
    distance walked over 6 minutes as a sub-maximal test of aerobic capacity

  • NT-proBNP [ Time Frame: 12 months ]
    N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

  • LV EF [ Time Frame: 12 month ]
    left ventricular (LV) ejection fraction (EF)


Enrollment: 15
Study Start Date: March 2015
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375399


Locations
Germany
Department of Cardiology, University of Heidelberg
Heidelberg, BW, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Mathias Konstandin, M.D. Heidelberg University
  More Information

Responsible Party: Mathias Konstandin, M.D., Heidelberg University
ClinicalTrials.gov Identifier: NCT02375399     History of Changes
Other Study ID Numbers: S-553/2012
First Submitted: February 24, 2015
First Posted: March 2, 2015
Last Update Posted: June 3, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases