TriangleNCT02584309 · OUTCOME
Ability of 3D Echocardiogram to Serve as an Early Marker of Cardiac Dysfunction Compared to 2D Echocardiogram Modified Simpson's Biplane Method of LVEF
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline and day 1 of each odd numbered cycle (each cycle is 21 days) up to 1 year
What was measured
* Cardiac dysfunction for this outcome measure is defined as moderate cancer therapy related cardiac dysfunction (CTRCD) as assessed by 2D Echocardiogram Modified Simpson's Biplane Method of LVEF. Moderate CTRCD is defined as \>10% ejection fraction drop to \<50%. * 3D echocardiograms were reviewed for evidence of cardiac dysfunction prior to onset of Moderate CTRCD by 2D echocardiogram. Dysfunction on 3D Echo was defined as \>10% ejection fraction drop to \<50%.
Analysis population: 13 participants were removed due to lack of analyzable 3D echo prior to onset of Moderate CTRCD or end of study.
Groups in this outcome
Arm 1: Doxorubicin and Upfront Dexrazoxane
* Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. * 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. * 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. * In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)
* Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. * Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. * The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.
| Group | Source count |
|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 46 |
| Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | 9 |
Reported measurements
Patients with moderate CTRCD by 2D echo
| Group | Source count |
|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 1 |
| Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | 0 |
Early dysfunction noted on 3D Echo
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | 0 | Not reported | Not reported | Not reported | Not reported |
No early dysfunction noted on 3D echo
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | 0 | Not reported | Not reported | Not reported | Not reported |
Patients without moderate CTRCD by 2D echo
| Group | Source count |
|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 45 |
| Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | 9 |
Early dysfunction noted on 3D Echo
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 7 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | 0 | Not reported | Not reported | Not reported | Not reported |
No early dysfunction noted on 3D echo
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Doxorubicin and Upfront Dexrazoxane | 38 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane) | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Early dysfunction noted on 3D Echo
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- No early dysfunction noted on 3D echo
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Patients with moderate CTRCD by 2D echo
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 0
- title
- Early dysfunction noted on 3D Echo
- measurements
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 9
- title
- No early dysfunction noted on 3D echo
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Patients without moderate CTRCD by 2D echo
- denoms
- counts
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- * Cardiac dysfunction for this outcome measure is defined as moderate cancer therapy related cardiac dysfunction (CTRCD) as assessed by 2D Echocardiogram Modified Simpson's Biplane Method of LVEF. Moderate CTRCD is defined as \>10% ejection fraction drop to \<50%. * 3D echocardiograms were reviewed for evidence of cardiac dysfunction prior to onset of Moderate CTRCD by 2D echocardiogram. Dysfunction on 3D Echo was defined as \>10% ejection fraction drop to \<50%.
- groups
- description
- * Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. * 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. * 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. * 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. * Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. * 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)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 13 participants were removed due to lack of analyzable 3D echo prior to onset of Moderate CTRCD or end of study.
- reporting Status
- POSTED
- time Frame
- Baseline and day 1 of each odd numbered cycle (each cycle is 21 days) up to 1 year
- title
- Ability of 3D Echocardiogram to Serve as an Early Marker of Cardiac Dysfunction Compared to 2D Echocardiogram Modified Simpson's Biplane Method of LVEF
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice