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NCT02717507 · OUTCOME

Average Left Ventricular End-systolic Volume

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
ml
Interval / dispersion
Standard Error
Time frame
Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation

What was measured

The amount of blood (in ml) in the heart's left ventricle just after the heart contracts. 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 ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)42.21931.3907Not reportedNot reportedNot reported
Arm II (Placebo)39.73541.3633Not reportedNot reportedNot reported
6m
Values in ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)41.61281.4041Not reportedNot reportedNot reported
Arm II (Placebo)41.38391.5337Not reportedNot reportedNot reported
12m
Values in ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)42.84371.3498Not reportedNot reportedNot reported
Arm II (Placebo)41.81131.6275Not reportedNot reportedNot reported
18m
Values in ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)43.14531.605Not reportedNot reportedNot reported
Arm II (Placebo)42.56342.1281Not reportedNot reportedNot reported
24m
Values in ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)42.00861.7268Not reportedNot reportedNot reported
Arm II (Placebo)42.4422.3661Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -5.34
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.951
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.605
    estimate Comment
    The treatment was considered efficacious if the group by time interaction for LVESV was statistically significant at a two-sided p\<0.05 and the expected LVESV was lower for carvedilol than placebo over time.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.17
    param Type
    Slope
    param Value
    -2.194
    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
    -5.34
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.951
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.605
    estimate Comment
    The treatment was considered efficacious if the group by time interaction for LVESV was statistically significant at a two-sided p\<0.05 and the expected LVESV was lower for carvedilol than placebo over time.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.17
    param Type
    Slope
    param Value
    -2.194
    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
        1.3907
        value
        42.2193
      2. group Id
        OG001
        spread
        1.3633
        value
        39.7354
    title
    BL
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.4041
        value
        41.6128
      2. group Id
        OG001
        spread
        1.5337
        value
        41.3839
    title
    6m
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.3498
        value
        42.8437
      2. group Id
        OG001
        spread
        1.6275
        value
        41.8113
    title
    12m
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.605
        value
        43.1453
      2. group Id
        OG001
        spread
        2.1281
        value
        42.5634
    title
    18m
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.7268
        value
        42.0086
      2. group Id
        OG001
        spread
        2.3661
        value
        42.442
    title
    24m
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      76
    units
    Participants
description
The amount of blood (in ml) in the heart's left ventricle just after the heart contracts. 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 End-systolic Volume
type
SECONDARY
unit Of Measure
ml

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Preserved source evidence · Not medical advice