Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Study never started due to change in standard of care guideline)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
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

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.

Condition or disease Intervention/treatment
Heart Failure Other: Extra echocardiogram

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


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


Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. Survival status [ Time Frame: through study completion, an average of 1 year ]
    alive or deceased

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
The Guthrie Clinic
Investigators
Layout table for investigator information
Principal Investigator: Philip Lowry, MD The Guthrie Clinic
Layout table for additonal information
Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT04413487    
Other Study ID Numbers: 20
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases