TriangleNCT02717507 · OUTCOME
Average Galectin-3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Error
- Time frame
- Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
What was measured
A protein produced by activated macrophages, and a member of a family of β-galactoside-binding lectings and promotes cardiac fibroblast proliferation and collagen synthesis following myocadial injury (in ng/ml). 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) | 4.4464 | 0.2625 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 5.2538 | 0.6531 | Not reported | Not reported | Not reported |
6m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 4.3252 | 0.2519 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 4.3735 | 0.2746 | Not reported | Not reported | Not reported |
12m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 3.7345 | 0.234 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 4.3415 | 0.327 | Not reported | Not reported | Not reported |
18m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 3.4548 | 0.2482 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 4.0214 | 0.2506 | Not reported | Not reported | Not reported |
24m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 3.8073 | 0.3099 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 4.0791 | 0.2853 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.468
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.424
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.228
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.92
- param Type
- Slope
- param Value
- -0.022
- 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
- -0.468
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.424
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.228
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.92
- param Type
- Slope
- param Value
- -0.022
- 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
- 0.2625
- value
- 4.4464
- group Id
- OG001
- spread
- 0.6531
- value
- 5.2538
- title
- BL
- categories
- measurements
- group Id
- OG000
- spread
- 0.2519
- value
- 4.3252
- group Id
- OG001
- spread
- 0.2746
- value
- 4.3735
- title
- 6m
- categories
- measurements
- group Id
- OG000
- spread
- 0.234
- value
- 3.7345
- group Id
- OG001
- spread
- 0.327
- value
- 4.3415
- title
- 12m
- categories
- measurements
- group Id
- OG000
- spread
- 0.2482
- value
- 3.4548
- group Id
- OG001
- spread
- 0.2506
- value
- 4.0214
- title
- 18m
- categories
- measurements
- group Id
- OG000
- spread
- 0.3099
- value
- 3.8073
- group Id
- OG001
- spread
- 0.2853
- value
- 4.0791
- title
- 24m
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 76
- units
- Participants
- description
- A protein produced by activated macrophages, and a member of a family of β-galactoside-binding lectings and promotes cardiac fibroblast proliferation and collagen synthesis following myocadial injury (in ng/ml). 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 Galectin-3
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice