Clinical trial Recruiting at 1 site Observational Ages 18 and up

3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy

Official title: A Prospective Observational Study of 3D Versus 2D Speckle-Tracking Echocardiography for Early Detection of Cardiotoxicity in Patients Treated With Anthracyclines and/or HER2-Targeted Therapy (SAFE-HEART)

Run by Region Skane · NCT07916337 · Data updated 2026-11-12

This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment130 (estimated)
SponsorRegion Skane
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Lund, Skåne County)
StatusRecruiting
StartedFebruary 3, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedNovember 4, 2026
Trial IDNCT07916337 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 or older with breast cancer, lymphoma, or sarcoma planned for anthracycline and/or HER2-targeted therapy and referred for baseline echocardiography at Skåne University Hospital.

Probably not a fit

Patients with inadequate image quality for 3D analysis, pregnancy, or inability to provide informed consent may not benefit from the study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, two-center observational study enrolls adults with breast cancer, lymphoma, or sarcoma who are planned to receive anthracyclines and/or HER2-targeted therapy. Participants undergo standardized echocardiography including both 2D and 3D strain analyses, with 3D left and right ventricular measurements and 3D LVEF, plus cardiac biomarkers at multiple time points. The goal is to determine if 3D speckle-tracking strain identifies subclinical cardiotoxicity earlier or more accurately than conventional 2D measures. Data will come from Skåne University Hospital in Lund and Malmö, Sweden. The study will help clarify the potential added value of 3D strain in monitoring CTRCD during cancer treatment.

Why it matters

Potential benefit: If successful, 3D strain could enable earlier detection of heart damage and allow timely interventions to protect the heart while continuing cancer therapy.

How similar studies have gone: Existing guidance supports 3D echocardiography for early detection of cardiotoxicity, but clinical evidence specific to 3D strain is still evolving; this study aims to add prospective data.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 18 years or older
* Diagnosis of breast cancer, lymphoma or sarcoma
* Scheduled for treatment with anthracyclines and/or HER2-targeted therapy
* Referred for baseline echocardiography before start of cancer therapy at Skåne University Hospital, Lund or Malmö
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Inability to provide informed consent
* Insufficient image quality for 3D speckle-tracking analysis at baseline echocardiography

Where it's running

  • Skåne University Hospital Lund and Malmö
    Lund, Skåne County, Sweden
    Recruiting

Study contacts

  • Principal investigator: Ashkan Labaf, MD, PhD — Skåne University Hospital and Lund University, Lund, Sweden
  • Study coordinator: Ashkan Labaf, MD, PhD
  • Email: ashkan.labaf@med.lu.se
  • Phone: +4646-171000

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.