Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy
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|ClinicalTrials.gov Identifier: NCT04413487|
Recruitment Status : Withdrawn (Study never started due to change in standard of care guideline)
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment|
|Heart Failure||Other: Extra echocardiogram|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Strain Echocardiogram in Early Detection of Left Ventricular Dysfunction in Cancer Patients Receiving Chemotherapy|
|Estimated Study Start Date :||March 2020|
|Actual Primary Completion Date :||May 28, 2020|
|Actual Study Completion Date :||May 28, 2020|
- Other: Extra echocardiogram
Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy
- Change in left ventricular ejection fraction (LVEF) [ Time Frame: 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%
- Survival status [ Time Frame: through study completion, an average of 1 year ]alive or deceased
- Change in symptoms that may be indicative of heart failure [ Time Frame: through study completion, an average of 1 year ]Presence of absence of symptoms
- Change in treatment that may be indicative of heart failure [ Time Frame: 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 [ Time Frame: through study completion, an average of 1 year ]Presence or absence of heart failure by imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413487
|Principal Investigator:||Philip Lowry, MD||The Guthrie Clinic|