An interventional study of Comprehensive echocardiographic follow-up and Simplified echocardiographic follow-up in Breast Neoplasm Malignant Primary, sponsored by Norwegian University of Science and Technology. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Diagnostic
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.
Cancer treatment related cardiac dysfunction (CTRCD) is a well-known complication to cancer treatment with implication both with respect to treatment and prognosis of the cancer as well as heart.
CTRCD, often named cardiotoxicity, usually refers to myocardial dysfunction and heart failure developing after administration of potentially cardiotoxic therapy. By precise diagnostics, adequate treatment can be started early to prevent heart failure and unnecessary discontinuation of the potential life-saving cancer treatment may be avoided. However, guideline advocated analyses of cardiac function (EF and GLS) by echocardiography are time consuming and many operators base their semi-quantitative estimates on visual assessment. Furthermore, test-retest variability for both EF and GLS are significant and may exceed the guideline recommended cut-offs for identification of cancer therapy-related cardiovascular toxicity.
The study will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomized design. The study will also evaluate if novel tools for improved standardization of recordings and automated measurements of relevant measurements as ejection fraction (EF) and global longitudinal strain (GLS) can improve the diagnostic precision.
Breast cancer patients referred for follow-up at the echocardiography will be included.
Patients will be randomized 1:1 to A) examinations with two- and three-dimensional echocardiography including all central measures of cardiac size and function measured by sonographers as recommended by the European guidelines and as clinical practice or B) echocardiographic examinations focusing on the ventricles.
Subpopulations will undergo additional testing with serial echocardiographic examinations by four operators on the same day with and without use of novel tools for improved standardization of recordings and automated measurements.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 250 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Standard of care echocardiographic follow-up
Diagnostic Test: Comprehensive echocardiographic follow-up
Simplified echocardiographic follow-up
Diagnostic Test: Simplified echocardiographic follow-up
Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients
Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients
Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)
Cancer treatment related cardiac dysfunction
Time frame: 15 months
Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD)
Proportion of misclassified CTRCD
Time frame: 15 months
Risk classification
Risk classification for identification of CTRCD
Time frame: 0 days
Risk classification
Risk classification for identification of CTRCD
Time frame: 15 months
Test-retest variability, systolic left ventricular size and function
Test-retest variability of systolic left ventricular size and function
Time frame: 0 days
Test-retest variability, systolic left ventricular size and function
Test-retest variability systolic left ventricular size and function
Time frame: 15 months
Test-retest variability, diastolic left ventricular size and function
Test-retest variability of diastolic left ventricular function
Time frame: 0 days
Test-retest variability, diastolic left ventricular size and function
Test-retest variability of diastolic left ventricular size and function
Time frame: 15 months
Test-retest variability, right ventricular size and function
Test-retest variability of right ventricular size and function
Time frame: 0 days
Test-retest variability, right ventricular size and function
Test-retest variability of right ventricular size and function
Time frame: 15 months
Time consumption
Time used for echocardiographic examination
Time frame: 0 days
Time consumption
Time used for echocardiographic examination
Time frame: 15 days
Plan to share: No
Started Mar 2024 (actual). Primary completion is estimated for Dec 2026, 33 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 33 months is close to that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
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