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NCT02717507 · OUTCOME

Average Cardiac N-terminal Pro B-type Natriuretic Peptide

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
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

N-terminal pro 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 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 pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)85.630113.3731Not reportedNot reportedNot reported
Arm II (Placebo)115.722222.243Not reportedNot reportedNot reported
6m
Values in pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)90.753611.7877Not reportedNot reportedNot reported
Arm II (Placebo)128.956523.736Not reportedNot reportedNot reported
12m
Values in pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)87.716713.38Not reportedNot reportedNot reported
Arm II (Placebo)115.636426.823Not reportedNot reportedNot reported
18m
Values in pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)99.491215.7275Not reportedNot reportedNot reported
Arm II (Placebo)93.210518.5618Not reportedNot reportedNot reported
24m
Values in pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)101.833314.2521Not reportedNot reportedNot reported
Arm II (Placebo)107.849026.6515Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -11.608
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    21.835
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    8.532
    estimate Comment
    The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.55
    param Type
    Slope
    param Value
    5.113
    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
    -11.608
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    21.835
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    8.532
    estimate Comment
    The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.55
    param Type
    Slope
    param Value
    5.113
    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
        13.3731
        value
        85.6301
      2. group Id
        OG001
        spread
        22.243
        value
        115.7222
    title
    BL
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.7877
        value
        90.7536
      2. group Id
        OG001
        spread
        23.736
        value
        128.9565
    title
    6m
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.38
        value
        87.7167
      2. group Id
        OG001
        spread
        26.823
        value
        115.6364
    title
    12m
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.7275
        value
        99.4912
      2. group Id
        OG001
        spread
        18.5618
        value
        93.2105
    title
    18m
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.2521
        value
        101.8333
      2. group Id
        OG001
        spread
        26.6515
        value
        107.8490
    title
    24m
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      76
    units
    Participants
description
N-terminal pro 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
  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 Cardiac N-terminal Pro B-type Natriuretic Peptide
type
SECONDARY
unit Of Measure
pg/mL

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Preserved source evidence · Not medical advice