Clinical Research

The overall objective of this NIH-funded longitudinal prospective cohort study (NCT01173341) is to determine the role of individual patient characteristics, mechanistic biomarkers, and novel echocardiographic measures of cardiac function in predicting the short- and long-term cardiovascular disease risk in women with breast cancer receiving potentially cardiotoxic therapy including hormone therapies, anthracyclines, HER2+ targeted therapies and radiation.

Principal Investigator: Dr. Bonnie Ky, MD, MSCE

The objectives of this AHA-funded Strategically Focused Research Network Award longitudinal prospective cohort study (NCT 05078190) in women with breast cancer are to determine the associations between individual and structural social determinants of health (SDOH) and cardiotoxicity risk, and how this may differ according to race. A sub-study of this protocol includes a detailed study of allostatic load, characterized as the “wear and tear” from chronic levels of stress placed on physiological systems. 

Principal Investigator: Dr. Bonnie Ky, MD, MSCE

Dr. Yehoda Martei, MD, MSCE was recently awarded a Robert A Winn Diversity in Clinical Trials Career Development Award for work in cardio-oncology clinical studies – her pilot proposal focuses on using community health workers to increase diversity in enrollment of two ongoing longitudinal prospective cohort studies, CCT2 and PCT, in cardio-oncology.

This NIH-funded, Phase I, single center, randomized clinical trial (NCT04023110) seeks to determine if a risk guided treatment strategy, as determined by a clinical risk score, that randomizes elevated cardiovascular risk breast cancer patients prior to doxorubicin and/or trastuzumab to carvedilol or usual care is safe, tolerable, and feasible. 

Principal Investigator: Dr. Bonnie Ky, MD, MSCE

This is a Phase I, multi-center, randomized trial (NCT04737265) of a biomarker-guided strategy using NT-proBNP to identify and treat patients at elevated risk of anthracycline therapy-related cardiotoxicity. The primary objective of this study is to determine if a biomarker guided strategy is feasible and well-tolerated in breast cancer or lymphoma patients treated with doxorubicin. 

Principal Investigator: Dr. Bonnie Ky, MD, MSCE

The overall objectives of this NIH-funded ancillary study (NCT04361240) to the RadComp clinical trial are to determine how early subclinical measures of cardiovascular injury and dysfunction differ according to radiation therapy type (proton vs photon) and which radiation therapy dose-volume parameters influence these markers. 

Principal Investigators: Dr. Bonnie Ky, MD, MSCE and Dr. Justin Bekelman, MD

The overall objective of this pilot study is to define how baseline CV risk differs according to HIV status in breast cancer patients treated with doxorubicin and/or trastuzumab. Our team also seeks to define the association between HIV infection and risk of left ventricular ejection fraction (LVEF) declines and Cancer Therapeutics Related Cardiac Dysfunction (CTRCD) in breast cancer patients treated with doxorubicin and/or trastuzumab. 

Principal Investigator: Dr. Bonnie Ky, MD, MSCE

Through an NIH-funded K24 grant, we are leveraging the electronic medical records (EMR) of the University of Pennsylvania Health System to determine the impact of race and the SDOH in cardio-oncology through a detailed analysis of patient-level data. We use the EMR to derive large breast and prostate cancer cohorts of patients receiving cardiotoxic cancer therapies and define the individual and structural SDOH and associations with cardiovascular clinical outcomes. 

Principal Investigator: Dr. Bonnie Ky, MD, MSCE

This is a Phase I, multi-center, randomized trial (NCT04737265) of a biomarker-guided strategy using NT-proBNP to identify and treat patients at elevated risk of anthracycline therapy-related cardiotoxicity. The primary objective of this study is to determine if a biomarker guided strategy is feasible and well-tolerated in breast cancer or lymphoma patients treated with doxorubicin. 

Principal Investigator: Dr. Bonnie Ky, MD, MSCE

CLARITY is a NIH-funded, multi-center, longitudinal prospective cohort study (NCT04305613) of lung cancer patients treated with radiation therapy with the objectives being to determine associations between radiation therapy dose-volume metrics and changes in biologic and imaging markers of cardiovascular function.  We aim to determine the prognostic value of these markers as indicators of adverse cardiovascular outcomes. 

Principal Investigator: Dr. Bonnie Ky, MD, MSCE

This Children’s Oncology Group phase III trial (NCT04293562) led by Dr. Todd M. Cooper, DO compares standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations.   

Children's Hospital of Philadelphia Site Principal Investigator: Richard Aplenc, MD, PhD, MSCE

AAML 1831 Cardiac Studies Principal Instigator: Dr. Kasey Joanne Leger, MD, MSc 

Echocardiography Core Lab Principal Investigator: Dr. Bonnie Ky, MD, MSCE

The primary objectives of this AHA-funded Strategically Focused Research Network Award longitudinal prospective cohort study (NCT05096338) in men with prostate cancer are to determine the associations between individual and structural SDOH and cardiotoxicity risk, and how this may differ according to race. A sub-study of this protocol also includes a detailed study of allostatic load. 

Principal Investigator: Dr. Bonnie Ky, MD, MSCE

Dr. Yehoda Martei, MD, MSCE was recently awarded a Robert A Winn Diversity in Clinical Trials Career Development Award for work in cardio-oncology clinical studies – her pilot proposal focuses on using community health workers to increase diversity in enrollment of two ongoing longitudinal prospective cohort studies, CCT2 and PCT, in cardio-oncology.

The overall objective of this NIH-funded Phase II clinical trial (NCT04467021) is to determine the feasibility of an Intensive (SBP< 120mmHg) Intervention versus Standard Care (SBP< 140mmHg) Non-Intervention approach to blood pressure (BP) control in metastatic renal cell and thyroid cancer patients initiating vascular endothelial growth factor receptor tyrosine kinase inhibitors. This study is being executed in collaboration with ECOG-ACRIN.  

Principal Investigators: Dr. Bonnie Ky, MD, MSCE and Dr. Kenneth Margulies, MD