Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy
- Conditions
- Heart Failure
- Registration Number
- NCT04413487
- Lead Sponsor
- The Guthrie Clinic
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in left ventricular ejection fraction (LVEF) through study completion, an average of 1 year 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%
- Secondary Outcome Measures
Name Time Method Survival status through study completion, an average of 1 year alive or deceased
Change in symptoms that may be indicative of heart failure through study completion, an average of 1 year Presence of absence of symptoms
Change in treatment that may be indicative of heart failure through study completion, an average of 1 year Presence or absence of treatment for heart failure
Change in strain echo that may be indicative of heart failure through study completion, an average of 1 year Presence or absence of heart failure by imaging