Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genetics and Heart Health After Cancer Therapy (Gene-HEART)

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: NCT03510689
Recruitment Status : Active, not recruiting
First Posted : April 27, 2018
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
The overall objective of this study is to use patient-centered in vitro and in vivo models to answer the fundamental question of whether or not pathogenic mutations in BRCA1/2 result in an increased risk of CV disease

Condition or disease Intervention/treatment
Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2) Heart Diseases Drug-Induced Cardiomyopathy Diagnostic Test: echocardiography Other: Cardiopulmonary Exercise Testing Other: Blood Collection

Layout table for study information
Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetics and Heart Health After Cancer Therapy
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2024


Group/Cohort Intervention/treatment
Group 1
Subjects with genetic testing confirming deleterious mutations in BRCA1 or BRCA2 whose prior treatment for breast cancer includes anthracycline exposure. All groups have same schedule of study procedures, including echocardiography, cardiopulmonary exercise testing, and blood collection.
Diagnostic Test: echocardiography
Resting echocardiograms (Vivid E9 or E95, GE Healthcare) with conventional measures of systolic and diastolic function, in conjunction with posthoc quantitation of novel measures of strain and strain rate will be obtained at each study time point.

Other: Cardiopulmonary Exercise Testing
A cardiopulmonary exercise test (CPET, also called V02 test) will be completed at each study time point utilizing a standard clinical protocol, on either a stationary bike or treadmill. The purpose of this test is to estimate maximal oxygen consumption (V02 max) as in index of cardiopulmonary fitness. Resting ECG, heart rate, and BP will be obtained prior to beginning the test, during each stage of the test and for 5 minutes after the test is stopped.

Other: Blood Collection
We will obtain blood samples (approximately 16mL) at baseline and (approximately 12mL) at each follow-up visit. Typically these will be drawn via peripheral venipuncture, however if patients have a port-a-cath in place, blood may be drawn from the port instead.

Group 2
Subjects with genetic testing confirming deleterious mutations in BRCA1 or BRCA2 whose prior treatment for breast cancer does not include anthracycline exposure. All groups have same schedule of study procedures, including echocardiography, cardiopulmonary exercise testing, and blood collection.
Diagnostic Test: echocardiography
Resting echocardiograms (Vivid E9 or E95, GE Healthcare) with conventional measures of systolic and diastolic function, in conjunction with posthoc quantitation of novel measures of strain and strain rate will be obtained at each study time point.

Other: Cardiopulmonary Exercise Testing
A cardiopulmonary exercise test (CPET, also called V02 test) will be completed at each study time point utilizing a standard clinical protocol, on either a stationary bike or treadmill. The purpose of this test is to estimate maximal oxygen consumption (V02 max) as in index of cardiopulmonary fitness. Resting ECG, heart rate, and BP will be obtained prior to beginning the test, during each stage of the test and for 5 minutes after the test is stopped.

Other: Blood Collection
We will obtain blood samples (approximately 16mL) at baseline and (approximately 12mL) at each follow-up visit. Typically these will be drawn via peripheral venipuncture, however if patients have a port-a-cath in place, blood may be drawn from the port instead.

Group 3
Subjects with genetic testing confirming no mutation in BRCA1 or BRCA2 whose prior treatment for breast cancer includes anthracycline exposure. All groups have same schedule of study procedures, including echocardiography, cardiopulmonary exercise testing, and blood collection.
Diagnostic Test: echocardiography
Resting echocardiograms (Vivid E9 or E95, GE Healthcare) with conventional measures of systolic and diastolic function, in conjunction with posthoc quantitation of novel measures of strain and strain rate will be obtained at each study time point.

Other: Cardiopulmonary Exercise Testing
A cardiopulmonary exercise test (CPET, also called V02 test) will be completed at each study time point utilizing a standard clinical protocol, on either a stationary bike or treadmill. The purpose of this test is to estimate maximal oxygen consumption (V02 max) as in index of cardiopulmonary fitness. Resting ECG, heart rate, and BP will be obtained prior to beginning the test, during each stage of the test and for 5 minutes after the test is stopped.

Other: Blood Collection
We will obtain blood samples (approximately 16mL) at baseline and (approximately 12mL) at each follow-up visit. Typically these will be drawn via peripheral venipuncture, however if patients have a port-a-cath in place, blood may be drawn from the port instead.




Primary Outcome Measures :
  1. Left Ventricular Ejection Fraction [ Time Frame: 6 years ]


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:   Probability Sample
Study Population
Initial diagnosis of Breast Cancer in 2005 or later BRCA testing documenting either germline mutation in BRCA1/BRCA2 or no mutation in BRCA1/2.
Criteria

Inclusion Criteria

  • ≥18 years of age
  • Initial diagnosis of Breast Cancer in 2005 or later
  • Documented BRCA testing (results from a local laboratory are acceptable) showing

    • confirmation of a germline mutation in BRCA1 or BRCA2 that is predicted or suspected to be deleterious OR
    • confirmation that no mutation was detected in BRCA1 or BRCA2
  • Non-carriers will have been treated with an anthracycline-based chemotherapy regimen; carriers may or may not have been treated with an anthracycline-based chemotherapy regimen.
  • Approximately at least 12 months from initiation of adjuvant treatment or neo-adjuvant chemotherapy
  • Able to provide informed consent

Exclusion Criteria

  • Stage IV Breast Cancer
  • Genetic testing confirming a variant of unknown significance (VUS) or benign polymorphism in BRCA1 or BRCA2
  • V02 Testing contraindicated for any reason, including:

    • Myocardial infarction (within past 3 months)
    • High-risk unstable angina;
    • High-risk or uncontrolled cardiac arrhythmias;
    • Symptomatic severe aortic stenosis;
    • Uncontrolled symptomatic heart failure;
    • Acute pulmonary embolus or pulmonary infarction;
    • Acute myocarditis or pericarditis;
    • Acute aortic dissection;
    • Coronary revascularization procedure within the past three months;
    • Uncontrolled hypertension, defined as systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg;
    • Clinically significant valvular heart disease (severe stenosis or regurgitation);
    • Known aortic aneurysm; or
    • Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the V02 test
  • Women who are pregnant
  • Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

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): NCT03510689


Locations
Layout table for location information
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Bonnie Ky, MD Abramson Cancer Center of the University of Pennsylvania
Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03510689    
Other Study ID Numbers: UPCC 13117
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Cardio-oncology
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiomyopathies
Cardiovascular Diseases