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NCT Number: NCT04467411

The EMBRACE Study The EMBRACE Study

Cardiomyopathy is a condition that affects the heart muscle, whereby it becomes enlarged, thick or rigid. When the heart muscle becomes involved, it affects the pumping action of the heart. This condition can affect as many as 10% of all patients after undergoing anthracycline cancer drug therapy and unfortunately carries the worst prognosis of all cardiomyopathies. To date, there is no effective intervention that will prevent a patient from developing this condition. The research conducted will look to see if an energy imbalance in the heart predates the onset of detrimental changes to the pumping function of the heart, if this is detected then we can act earlier to prevent the pumping function deteriorating.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cardiac Research Office, Aberdeen Royal Infirmary, Aberdeen, Aberdeenshire, United Kingdom

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About this study

There is emerging cellular and experimental evidence that cardiac energetic status is reduced after anthracycline treatment, however, this has not been tested in the human heart. The researchers hypothesize that cardiac energetic status is reduced in the human heart after administration of anthracycline therapy in breast cancer patients, inline with the evidence available from all other types of cardiomyopathies. The researchers propose to use in vivo 31Phosphorus cardiac spectroscopy to measure the cardiac energetic status at the beginning and at the end of the cycles of chemotherapy in the hearts of breast cancer patients who are administered epirubicin (the most modern anthracycline to date) and compare this with the cardiac energetic status of age and gender matched healthy controls. Further, the researchers wish to explore if the myopathy-induced effect of anthracyclines extends to the skeletal muscle as well, by examining skeletal muscle biopsies in these patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A patient who has been diagnosed with breast cancer and has been scheduled for a first cycle of anthracycline therapy.
  • Participant who is willing and able to give informed consent for participation in the study.
  • Healthy (gender and age matched) volunteers willing to give informed consent for participation in the study.

Exclusion criteria

  • Contraindication to magnetic resonance scanning such as an implantable cardiac device.

Treatment and study plan

Primary outcomes

  1. Cardiac Energetics

    Time frame: At baseline

    Cardiac MRI and MRS

  2. Cardiac Energetics

    Time frame: Through study completion, up to sixteen weeks

    Cardiac MRI and MRS

Secondary outcomes

  1. Cardiac Imaging

    Time frame: At baseline

    Echocardiography

  2. Cardiac Imaging

    Time frame: Through study completion, up to sixteen weeks

    Echocardiography

  3. Blood Biomarkers

    Time frame: At baseline

    BNP and Troponins

  4. Blood Biomarkers

    Time frame: Through study completion, up to sixteen weeks

    BNP and Troponins

  5. Histology

    Time frame: At baseline

    Histology of skeletal muscle biopsies

  6. Histology

    Time frame: Through study completion, up to sixteen weeks

    Histology of skeletal muscle biopsies

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

Randomised Controlled Study of Physical Exercise Intervention in Breast Cancer Patients at Risk of Anthracycline-induced Cardiomyopathy:The EMBRACE Study

Acronym: EMBRACE

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jul 13, 2020
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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