Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04413487
• Other study ID #: 20
• Status: Withdrawn
• Start date: March 2020
• Est. completion date: May 28, 2020

Study information

• Verified date: May 2020
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Extra echocardiogram
Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival status	alive or deceased	through study completion, an average of 1 year
Secondary	Change in symptoms that may be indicative of heart failure	Presence of absence of symptoms	through study completion, an average of 1 year
Secondary	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
Secondary	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