NCT00541801

Brief Summary

In this study, the investigators sought to determine whether an acoustic cardiographic assessment of heart function is equivalent to Doppler-echocardiography in patients who are treated with cardio-toxic cytostatic agents.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

4.3 years

First QC Date

October 8, 2007

Last Update Submit

June 22, 2011

Conditions

Heart Failure, CongestiveAntineoplastic Agents

Outcome Measures

Primary Outcomes (1)

  • Changes of echocardiographic parameters and changes of electromechanical activation time (EMAT)and development of third heart sound as indicators of congestive heart failure

    Repeated measurements over a year

Secondary Outcomes (1)

  • Development of clinically overt congestive heart failure

    One year

Interventions

Doppler-echocardiography and acoustic cardiographyDEVICE

Patients receive a Doppler-echocardiography and an acoustic cardiography

Eligibility Criteria

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

You may qualify if:

  • Patients with malignant disease with scheduled anthracycline and trastuzumab therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Luzern, Department of Cardiology

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Echocardiography, Doppler

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyUltrasonography, DopplerHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Paul Erne, MD

    Luzerner Kantonsspital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2007

First Posted

October 10, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

CH(1)