TriangleNCT02717507 · OUTCOME
Average Fractional Shortening
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent
- Interval / dispersion
- Standard Error
- Time frame
- Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
What was measured
A measure to assess preload and afterload (in %). The mean is reported by arm at each timepoint with corresponding standard errors.
Analysis population: We excluded 31 participants who did not have a second time point assessment of echocardiography, resulting in 151 analyzable participants.
Groups in this outcome
Arm I (Carvedilol)
Patients received Carvedilol PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
Arm II (Placebo)
Patients received Placebo PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
| Group | Source count |
|---|---|
| Arm I (Carvedilol) | 75 |
| Arm II (Placebo) | 76 |
Reported measurements
BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 28.5362 | 0.4549 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 28.4339 | 0.4764 | Not reported | Not reported | Not reported |
6m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 28.5409 | 0.4738 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 27.6866 | 0.5799 | Not reported | Not reported | Not reported |
12m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 29.6121 | 0.483 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 28.1085 | 0.4918 | Not reported | Not reported | Not reported |
18m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 27.8219 | 0.4951 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 27.8891 | 0.596 | Not reported | Not reported | Not reported |
24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 28.0302 | 0.5073 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 28.5953 | 0.5901 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.652
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.532
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.302
- estimate Comment
- The treatment can be considered beneficial if the mean difference (treatment - control) slope is positive
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.84
- param Type
- Slope
- param Value
- -0.060
- statistical Comment
- The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.
- statistical Method
- Generalized Estimating Equation (GEE)
Complete source fields
- analyses
- ci Lower Limit
- -0.652
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.532
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.302
- estimate Comment
- The treatment can be considered beneficial if the mean difference (treatment - control) slope is positive
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.84
- param Type
- Slope
- param Value
- -0.060
- statistical Comment
- The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.
- statistical Method
- Generalized Estimating Equation (GEE)
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.4549
- value
- 28.5362
- group Id
- OG001
- spread
- 0.4764
- value
- 28.4339
- title
- BL
- categories
- measurements
- group Id
- OG000
- spread
- 0.4738
- value
- 28.5409
- group Id
- OG001
- spread
- 0.5799
- value
- 27.6866
- title
- 6m
- categories
- measurements
- group Id
- OG000
- spread
- 0.483
- value
- 29.6121
- group Id
- OG001
- spread
- 0.4918
- value
- 28.1085
- title
- 12m
- categories
- measurements
- group Id
- OG000
- spread
- 0.4951
- value
- 27.8219
- group Id
- OG001
- spread
- 0.596
- value
- 27.8891
- title
- 18m
- categories
- measurements
- group Id
- OG000
- spread
- 0.5073
- value
- 28.0302
- group Id
- OG001
- spread
- 0.5901
- value
- 28.5953
- title
- 24
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 76
- units
- Participants
- description
- A measure to assess preload and afterload (in %). The mean is reported by arm at each timepoint with corresponding standard errors.
- dispersion Type
- Standard Error
- groups
- description
- Patients received Carvedilol PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
- id
- OG000
- title
- Arm I (Carvedilol)
- description
- Patients received Placebo PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
- id
- OG001
- title
- Arm II (Placebo)
- param Type
- MEAN
- population Description
- We excluded 31 participants who did not have a second time point assessment of echocardiography, resulting in 151 analyzable participants.
- reporting Status
- POSTED
- time Frame
- Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
- title
- Average Fractional Shortening
- type
- SECONDARY
- unit Of Measure
- percent
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice