NCT02717507 · OUTCOME
Average N-terminal Pro B-type Natriuretic Peptide
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- pg/mL
- Interval / dispersion
- Standard Error
- Time frame
- Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
What was measured
B-type natriuretic peptide- a biomarker for heart failure (in pg/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) | 27.3836 | 2.0697 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 31.4324 | 3.424 | Not reported | Not reported | Not reported |
6m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 31.8406 | 3.3339 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 34.1857 | 3.4737 | Not reported | Not reported | Not reported |
12m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 26.8203 | 3.4625 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 33.2941 | 4.095 | Not reported | Not reported | Not reported |
18m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 35.807 | 3.7939 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 32.2807 | 4.0405 | Not reported | Not reported | Not reported |
24m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 34.625 | 3.0875 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 33.3774 | 3.6481 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.387
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.63
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.79
- estimate Comment
- The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.24
- param Type
- Slope
- param Value
- 2.121
- 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
- -1.387
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.63
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.79
- estimate Comment
- The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.24
- param Type
- Slope
- param Value
- 2.121
- 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
- 2.0697
- value
- 27.3836
- group Id
- OG001
- spread
- 3.424
- value
- 31.4324
- title
- BL
- categories
- measurements
- group Id
- OG000
- spread
- 3.3339
- value
- 31.8406
- group Id
- OG001
- spread
- 3.4737
- value
- 34.1857
- title
- 6m
- categories
- measurements
- group Id
- OG000
- spread
- 3.4625
- value
- 26.8203
- group Id
- OG001
- spread
- 4.095
- value
- 33.2941
- title
- 12m
- categories
- measurements
- group Id
- OG000
- spread
- 3.7939
- value
- 35.807
- group Id
- OG001
- spread
- 4.0405
- value
- 32.2807
- title
- 18m
- categories
- measurements
- group Id
- OG000
- spread
- 3.0875
- value
- 34.625
- group Id
- OG001
- spread
- 3.6481
- value
- 33.3774
- title
- 24m
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 76
- units
- Participants
- description
- B-type natriuretic peptide- a biomarker for heart failure (in pg/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 N-terminal Pro B-type Natriuretic Peptide
- type
- SECONDARY
- unit Of Measure
- pg/mL
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Preserved source evidence · Not medical advice
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