{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"}]}],"title":"Moderate cancer therapy related cardiac dysfunction (CTRCD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"4"}]}],"title":"Mild cancer therapy related cardiac dysfunction (CTRCD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Heart failure with mildly reduced ejection fraction (HfmrEF)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"1"}]}],"title":"Heart failure with preserved ejection fraction (HFpEF)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"description":"* Cardiomyopathy is now referred to as cancer therapy related cardiac dysfunction (CTRCD) by the recent consensus statement of the International Cardio-Oncology Society. Moderate CTRCD is defined as \\>10% ejection fraction drop to \\<50%. Mild CTRCD is defined as drop in ≥15% ventricular strain or if no ventricular strain, a drop in ejection fraction of ≥50%.\n* Heart failure is defined according to the recent Universal Definition and Classification of Heart Failure: A Report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure.","groups":[{"description":"* Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given.\n* Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle.\n* Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2.\n* In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..","id":"OG000","title":"Arm 1: Doxorubicin and Upfront Dexrazoxane"},{"description":"* Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle.\n* Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles.\n* The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.","id":"OG001","title":"Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 12 months","title":"Percentage of Patients With Heart Failure or Cardiomyopathy","type":"SECONDARY","unitOfMeasure":"Participants"}