TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
- Conditions
- Breast Neoplasm Malignant Primary
- Interventions
- Diagnostic Test: Comprehensive echocardiographic follow-upDiagnostic Test: Simplified echocardiographic follow-up
- Registration Number
- NCT06310330
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Breast cancer and referral for follow-up to identify potential CTRCD
- Not willing or able to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Comprehensive echocardiographic follow-up Standard of care echocardiographic follow-up Simplified care Simplified echocardiographic follow-up Simplified echocardiographic follow-up
- Primary Outcome Measures
Name Time Method Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD) 15 months Cancer treatment related cardiac dysfunction
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Olavs hospital
🇳🇴Trondheim, Norway