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NCT02717507 · OUTCOME

Average Left-Ventricular Wall Thickness-Dimension Ratio Z-score (LVWT/Dz)

Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors · Source last updated 2025-04-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
z-score
Interval / dispersion
Standard Error
Time frame
Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation

What was measured

Z-score of the ratio of left ventricular (LV) posterior wall dimension of systole to internal LV dimension in diastole, calculated for each subject by subtracting the reference healthy population mean, then dividing by the standard deviation. The Z-score indicates the number of standard deviations away from the mean of the reference population. Negative Z- score indicates worse outcome. 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (Carvedilol)75
Arm II (Placebo)76

Reported measurements

BL
Values in z-score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)-0.13720.1711Not reportedNot reportedNot reported
Arm II (Placebo)-0.08930.1917Not reportedNot reportedNot reported
6m
Values in z-score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)-0.21670.167Not reportedNot reportedNot reported
Arm II (Placebo)0.32150.154Not reportedNot reportedNot reported
12m
Values in z-score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)-0.24160.1721Not reportedNot reportedNot reported
Arm II (Placebo)-0.23670.1822Not reportedNot reportedNot reported
18m
Values in z-score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)-0.23750.21Not reportedNot reportedNot reported
Arm II (Placebo)-0.19740.1976Not reportedNot reportedNot reported
24m
Values in z-score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.02130.2353Not reportedNot reportedNot reported
Arm II (Placebo)-0.18340.2145Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.057
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.383
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.112
    estimate Comment
    The treatment was considered efficacious if the group by time interaction for LVWT/Dz was statistically significant at a two-sided p\<0.05 and the expected LVWT/Dz was higher for carvedilol than placebo over time.
    group Description
    The null hypothesis is that change in LVWT/Dz across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 0.6-0.8 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVWT/Dz at 24m.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.15
    param Type
    Slope
    param Value
    0.163
    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
  1. ci Lower Limit
    -0.057
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.383
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.112
    estimate Comment
    The treatment was considered efficacious if the group by time interaction for LVWT/Dz was statistically significant at a two-sided p\<0.05 and the expected LVWT/Dz was higher for carvedilol than placebo over time.
    group Description
    The null hypothesis is that change in LVWT/Dz across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 0.6-0.8 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVWT/Dz at 24m.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.15
    param Type
    Slope
    param Value
    0.163
    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
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1711
        value
        -0.1372
      2. group Id
        OG001
        spread
        0.1917
        value
        -0.0893
    title
    BL
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.167
        value
        -0.2167
      2. group Id
        OG001
        spread
        0.154
        value
        0.3215
    title
    6m
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1721
        value
        -0.2416
      2. group Id
        OG001
        spread
        0.1822
        value
        -0.2367
    title
    12m
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.21
        value
        -0.2375
      2. group Id
        OG001
        spread
        0.1976
        value
        -0.1974
    title
    18m
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.2353
        value
        0.0213
      2. group Id
        OG001
        spread
        0.2145
        value
        -0.1834
    title
    24m
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      76
    units
    Participants
description
Z-score of the ratio of left ventricular (LV) posterior wall dimension of systole to internal LV dimension in diastole, calculated for each subject by subtracting the reference healthy population mean, then dividing by the standard deviation. The Z-score indicates the number of standard deviations away from the mean of the reference population. Negative Z- score indicates worse outcome. The mean is reported by arm at each timepoint with corresponding standard errors.
dispersion Type
Standard Error
groups
  1. 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)
  2. 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 Wall Thickness-Dimension Ratio Z-score (LVWT/Dz)
type
PRIMARY
unit Of Measure
z-score

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Preserved source evidence · Not medical advice