Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy

NCT ID: NCT04413487

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2020-05-28

Brief Summary

Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease. Subjects will received an extra echocardiogram to determine if heart problems can be detected earlier.

Detailed Description

• Patients scheduled for potentially cardiotoxic chemotherapy would receive a baseline echocardiogram as per standard protocol which should be covered by the routine insurance
• Follow-up with an extra echocardiogram for research purposes would be performed after 2 cycles of that chemotherapy - supplied by the study
• Clinical assessment at 3 to 6 months including repeat echocardiography as per standard care with the research question as whether any differences in strain pattern between pre-chemo and post 2 cycles studies all identify patients who are more likely to have cardiac issues later.
• Patients will have standard of care visits at 3 month, 6 month and 12 month and will be evaluated for cardiac status and survival.
• Patient records will be reviewed at 5 years to check cardiac status and survival.

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Extra echocardiogram

Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males and females 18 years and above
• Willing and able to provide consent
• Able to read
• Patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab.
• Patients at increased risk of cardiotoxicity with one or more risk factors for heart disease:

• LVEF 50-54% by baseline echocardiogram
• Age ≥ 65
• BMI ≥ 30 kg/m2
• Current or prior anti-hypertensive therapy
• Diagnosis of coronary artery disease (CAD)
• Diabetes Mellitus
• Atrial fibrillation/flutter

Exclusion Criteria

• Children
• Patients who are pregnant
• Only single encounter without follow up
• Cancer diagnosis other than breast or hematological cancer
• Chemotherapy treatment other than anthracycline or trastuzumab
• No prior chemotherapy treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Guthrie Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Lowry, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Other Identifiers

20

Identifier Type: -

Identifier Source: org_study_id