- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04413487
Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy
May 28, 2020 updated by: The Guthrie Clinic
Strain Echocardiogram in Early Detection of Left Ventricular Dysfunction in Cancer Patients Receiving Chemotherapy
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.
Study Overview
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.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival status
Time Frame: through study completion, an average of 1 year
|
alive or deceased
|
through study completion, an average of 1 year
|
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
|
through study completion, an average of 1 year
|
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
|
through study completion, an average of 1 year
|
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
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philip Lowry, MD, The Guthrie Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2020
Primary Completion (Actual)
May 28, 2020
Study Completion (Actual)
May 28, 2020
Study Registration Dates
First Submitted
December 9, 2019
First Submitted That Met QC Criteria
May 28, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
June 4, 2020
Last Update Submitted That Met QC Criteria
May 28, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20 (Sophies Minde Ortopedi AS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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