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

Status

Withdrawn

Conditions

Intervention / Treatment

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.

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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