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NCT02420223 · OUTCOME

Beta-adrenergically Mediated Gene Expression (Change From Baseline)

Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients · Source last updated 2021-06-07

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

Measure
MEAN
Unit
Unitless
Interval / dispersion
Standard Error
Time frame
Baseline (Pre-Transplant); 4 weeks post-transplant

What was measured

Expression (up or down regulation) of genes involved in the stress response can be modulated through the beta-adrenergic pathway. The log2 RNA abundance is a means to normalize results to determine whether a gene is up regulated (value greater than 1) or down regulated (value less than 1). Differential change in log2 RNA abundance is defined by the fold change (FC) as log2FC=Log2(B)-Log2(A). Logarithmic measures are unitless. The change in the measure between two time points determines whether a gene has up-or down-regulated.

Groups in this outcome

Propranolol

Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm. Propranolol

Control Arm

Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Propranolol12
Control Arm13

Reported measurements

Source class 1
Values in Unitless · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Propranolol-0.4070.165Not reportedNot reportedNot reported
Control Arm0.00990.103Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .017
    statistical Method
    Regression, Logistic
  2. group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.337
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .017
    statistical Method
    Regression, Logistic
  2. group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.337
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.165
        value
        -0.407
      2. group Id
        OG001
        spread
        0.103
        value
        0.0099
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Expression (up or down regulation) of genes involved in the stress response can be modulated through the beta-adrenergic pathway. The log2 RNA abundance is a means to normalize results to determine whether a gene is up regulated (value greater than 1) or down regulated (value less than 1). Differential change in log2 RNA abundance is defined by the fold change (FC) as log2FC=Log2(B)-Log2(A). Logarithmic measures are unitless. The change in the measure between two time points determines whether a gene has up-or down-regulated.
dispersion Type
Standard Error
groups
  1. description
    Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm. Propranolol
    id
    OG000
    title
    Propranolol
  2. description
    Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.
    id
    OG001
    title
    Control Arm
param Type
MEAN
reporting Status
POSTED
time Frame
Baseline (Pre-Transplant); 4 weeks post-transplant
title
Beta-adrenergically Mediated Gene Expression (Change From Baseline)
type
PRIMARY
unit Of Measure
Unitless

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice