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NCT01677286 · OUTCOME

Amyloid Cardiomyopathy: Troponin I

Safety and Effect of Doxycycline in Patients With Amyloidosis · Source last updated 2017-08-01

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
12 months

What was measured

Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at change at end of study reported

Analysis population: Patients with predominant amyloid involvement of the heart.

Groups in this outcome

Cardiomyopathy

Patients with predominant amyloid involvement of the heart.

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

Analysis denominator · Participants

GroupSource count
Cardiomyopathy12

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cardiomyopathy0.150.07Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -0.009
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0234
    group Description
    Troponin I ng/mL, baseline versus end study levels.
    group Ids
    1. OG000
    non Inferiority Comment
    P-values and confidence intervals are not adjusted for multiple testing
    non Inferiority Type
    OTHER
    p Value
    0.340
    param Type
    Mean outcome change
    param Value
    0.0072
    statistical Comment
    degrees of freedom = 12
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    -0.009
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0234
    group Description
    Troponin I ng/mL, baseline versus end study levels.
    group Ids
    1. OG000
    non Inferiority Comment
    P-values and confidence intervals are not adjusted for multiple testing
    non Inferiority Type
    OTHER
    p Value
    0.340
    param Type
    Mean outcome change
    param Value
    0.0072
    statistical Comment
    degrees of freedom = 12
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.07
        value
        0.15
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at change at end of study reported
dispersion Type
Standard Deviation
groups
  1. description
    Patients with predominant amyloid involvement of the heart.
    id
    OG000
    title
    Cardiomyopathy
param Type
MEAN
population Description
Patients with predominant amyloid involvement of the heart.
reporting Status
POSTED
time Frame
12 months
title
Amyloid Cardiomyopathy: Troponin I
type
PRIMARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice