TriangleNCT02717507 · OUTCOME
Average Peak Early Atrial Divided by Peak Late Atrial Velocities
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ratio
- Interval / dispersion
- Standard Error
- Time frame
- Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
What was measured
Ratio of peak velocity blood flow from left ventricular relaxation in early diastole (E wave) to peak velocity flow in late diastole caused by atrial contraction (A wave). "Number" shown for Unit of Measure refers to this ratio. Normal: \>1. Impaired: \<1. 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) | 1.728 | 0.067 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 1.732 | 0.071 | Not reported | Not reported | Not reported |
6m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 1.642 | 0.048 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 1.769 | 0.069 | Not reported | Not reported | Not reported |
12m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 1.723 | 0.065 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 1.722 | 0.079 | Not reported | Not reported | Not reported |
18m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 1.732 | 0.063 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 1.732 | 0.081 | Not reported | Not reported | Not reported |
24m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Carvedilol) | 1.603 | 0.063 | Not reported | Not reported | Not reported |
| Arm II (Placebo) | 1.64 | 0.074 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.065
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.082
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.038
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.82
- param Type
- Slope
- param Value
- 0.009
- 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
- -0.065
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.082
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.038
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.82
- param Type
- Slope
- param Value
- 0.009
- 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
- 0.067
- value
- 1.728
- group Id
- OG001
- spread
- 0.071
- value
- 1.732
- title
- BL
- categories
- measurements
- group Id
- OG000
- spread
- 0.048
- value
- 1.642
- group Id
- OG001
- spread
- 0.069
- value
- 1.769
- title
- 6m
- categories
- measurements
- group Id
- OG000
- spread
- 0.065
- value
- 1.723
- group Id
- OG001
- spread
- 0.079
- value
- 1.722
- title
- 12m
- categories
- measurements
- group Id
- OG000
- spread
- 0.063
- value
- 1.732
- group Id
- OG001
- spread
- 0.081
- value
- 1.732
- title
- 18m
- categories
- measurements
- group Id
- OG000
- spread
- 0.063
- value
- 1.603
- group Id
- OG001
- spread
- 0.074
- value
- 1.64
- title
- 24m
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 76
- units
- Participants
- description
- Ratio of peak velocity blood flow from left ventricular relaxation in early diastole (E wave) to peak velocity flow in late diastole caused by atrial contraction (A wave). "Number" shown for Unit of Measure refers to this ratio. Normal: \>1. Impaired: \<1. 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 Peak Early Atrial Divided by Peak Late Atrial Velocities
- type
- SECONDARY
- unit Of Measure
- ratio
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Preserved source evidence · Not medical advice