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Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04413487
Enrollment
0
Registered
2020-06-04
Start date
2020-03-31
Completion date
2020-05-28
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

OTHERExtra echocardiogram

Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy

Sponsors

The Guthrie Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in left ventricular ejection fraction (LVEF)through study completion, an average of 1 yeara 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

MeasureTime frameDescription
Survival statusthrough study completion, an average of 1 yearalive or deceased
Change in symptoms that may be indicative of heart failurethrough study completion, an average of 1 yearPresence of absence of symptoms
Change in treatment that may be indicative of heart failurethrough study completion, an average of 1 yearPresence or absence of treatment for heart failure
Change in strain echo that may be indicative of heart failurethrough study completion, an average of 1 yearPresence or absence of heart failure by imaging

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026