Clinical trial NCT04413487: Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy
Official title: Strain Echocardiogram in Early Detection of Left Ventricular Dysfunction in Cancer Patients Receiving Chemotherapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 including 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 or Atrial fibrillation/flutter.

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.

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

Primary outcomes:
measure: Change in left ventricular ejection fraction (LVEF)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Survival status
timeFrame: through study completion, an average of 1 year
measure: Change in symptoms that may be indicative of heart failure
timeFrame: through study completion, an average of 1 year
measure: Change in treatment that may be indicative of heart failure
timeFrame: through study completion, an average of 1 year
measure: Change in strain echo that may be indicative of heart failure
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The Guthrie Clinic
name: Philip Lowry, MD
role: PRINCIPAL_INVESTIGATOR
References: