TriangleNCT02717507 · OUTCOME
Average Left Ventricular End-systolic Wall Stress
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- g/cm^2
- Interval / dispersion
- Standard Error
- Time frame
- Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
What was measured
Echocardiographic measure of left ventricular (LV) afterload based on LV pressure (P), volume (V), and wall thickness (T), calculated by the formula (P x V)/T, which equals the number referred to below in the Measure Type. 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) | 93.2892 | 2.222 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 90.6135 | 2.9775 | Not reported | Not reported | Not reported |
6m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 90.3088 | 2.0577 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 96.8356 | 2.9025 | Not reported | Not reported | Not reported |
12m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 88.984 | 2.0069 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 96.0616 | 3.0406 | Not reported | Not reported | Not reported |
18m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 93.9267 | 2.4333 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 91.6458 | 3.1257 | Not reported | Not reported | Not reported |
24m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 89.2513 | 2.4341 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 94.0647 | 3.6562 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -7.105
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.424
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.705
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.03
- param Type
- Slope
- param Value
- -3.764
- 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
- -7.105
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.424
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.705
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.03
- param Type
- Slope
- param Value
- -3.764
- 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
- 2.222
- value
- 93.2892
- group Id
- OG001
- spread
- 2.9775
- value
- 90.6135
- title
- BL
- categories
- measurements
- group Id
- OG000
- spread
- 2.0577
- value
- 90.3088
- group Id
- OG001
- spread
- 2.9025
- value
- 96.8356
- title
- 6m
- categories
- measurements
- group Id
- OG000
- spread
- 2.0069
- value
- 88.984
- group Id
- OG001
- spread
- 3.0406
- value
- 96.0616
- title
- 12m
- categories
- measurements
- group Id
- OG000
- spread
- 2.4333
- value
- 93.9267
- group Id
- OG001
- spread
- 3.1257
- value
- 91.6458
- title
- 18m
- categories
- measurements
- group Id
- OG000
- spread
- 2.4341
- value
- 89.2513
- group Id
- OG001
- spread
- 3.6562
- value
- 94.0647
- title
- 24m
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 76
- units
- Participants
- description
- Echocardiographic measure of left ventricular (LV) afterload based on LV pressure (P), volume (V), and wall thickness (T), calculated by the formula (P x V)/T, which equals the number referred to below in the Measure Type. 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 Left Ventricular End-systolic Wall Stress
- type
- SECONDARY
- unit Of Measure
- g/cm^2
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Preserved source evidence · Not medical advice