Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Strain Echocardiogram in Early Detection of Left Ventricular Dysfunction in Cancer Patients Receiving Chemotherapy

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Extra echocardiogram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Extra echocardiogram|Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular ejection fraction (LVEF) | a decrease in LVEF of ≥10 percentage points from baseline to a value of < 50% OR a decrease of LVEF by ≥ 5 percentage points from baseline to LVEF <50% for patients who have a baseline LVEF of 50-54% | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival status | alive or deceased | through study completion, an average of 1 year | 
| Change in symptoms that may be indicative of heart failure | Presence of absence of symptoms | through study completion, an average of 1 year | 
| Change in treatment that may be indicative of heart failure | Presence or absence of treatment for heart failure | through study completion, an average of 1 year | 
| Change in strain echo that may be indicative of heart failure | Presence or absence of heart failure by imaging | through study completion, an average of 1 year |