NCT02375399

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

February 24, 2015

Last Update Submit

June 2, 2016

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (3)

  • 3D echocardiography

    offline analysis of echocardiography data

    12 months

  • 2D strain

    offline analysis of echocardiography data

    12 months

  • m-mode echocardiography

    offline analysis of echocardiography data

    12 months

Secondary Outcomes (4)

  • NYHA

    12 months

  • six-min walk test

    12 months

  • NT-proBNP

    12 months

  • LV EF

    12 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • congestive heart failure, dilated cardiomyopathy, indication for implantation of a CRT-device according to the European Society of Cardiology (ESC)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mathias Konstandin, M.D.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 2, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations

DE(1)