The EMBRACE Study The EMBRACE Study

NCT04467411 | Active Not Recruiting

• 1 other identifier: 2-049-18
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Cardiac Energetics

  Cardiac MRI and MRS

  At baseline

• Cardiac Energetics

  Cardiac MRI and MRS

  Through study completion, up to sixteen weeks

Secondary Outcomes (6)

• Cardiac Imaging

  At baseline

• Cardiac Imaging

  Through study completion, up to sixteen weeks

• Blood Biomarkers

  At baseline

• Blood Biomarkers

  Through study completion, up to sixteen weeks

• Histology

  At baseline

Study Arms (2)

Breast Cancer Group

Breast Cancer Group

Healthy Volunteer

Healthy Volunteer Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females are eligible to take part in the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers and patients diagnosed with breast cancer who have been scheduled for the first cycle of anthracycline therapy.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (2)

Cardiac Research Office, Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

Location

Cardiovascular Research Facility

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

Location

Related Publications (26)

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• Gamble DT, Ross J, Khan H, Unger A, Cheyne L, Rudd A, Saunders F, Srivanasan J, Kamya S, Horgan G, Hannah A, Baliga S, Tocchetti CG, Urquhart G, Linke WA, Masannat Y, Mustafa A, Fuller M, Elsberger B, Sharma R, Dawson D. Impaired Cardiac and Skeletal Muscle Energetics Following Anthracycline Therapy for Breast Cancer. Circ Cardiovasc Imaging. 2023 Oct;16(10):e015782. doi: 10.1161/CIRCIMAGING.123.015782. Epub 2023 Oct 17.

  PMID: 37847761 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and skeletal muscle biopsies

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Dana Dawson, MD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 13, 2020
• Study Start: February 1, 2020
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)