TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorwegian University of Science and Technology

About this trial

TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).

Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Breast cancer and referral for follow-up to identify potential CTRCD

Disqualifiers

Not willing or able to consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Comprehensive echocardiographic follow-up

    Diagnostic test

    Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients

  • Simplified echocardiographic follow-up

    Diagnostic test

    Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Usual careActive comparator 1 intervention
Group B: Simplified careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)

Cancer treatment related cardiac dysfunction

Time frame
15 months

Secondary outcomes

Other outcomes

1

Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD)

Proportion of misclassified CTRCD

Time frame
15 months
2

Risk classification

Risk classification for identification of CTRCD

Time frame
0 days
3

Risk classification

Risk classification for identification of CTRCD

Time frame
15 months
4

Test-retest variability, systolic left ventricular size and function

Test-retest variability of systolic left ventricular size and function

Time frame
0 days

Sponsors and contacts

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