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NCT01677286 · OUTCOME

Amyloid Cardiomyopathy: BNP

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
pg/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 end of study reported

Analysis population: Analysis is limited to the patients with predominant amyloid heart involvement at enrollment. Mixed models analyses of change from baseline levels of cardiac biomarkers (BNP, Troponin I) were performed to include all collected data.

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 pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cardiomyopathy883703Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    14.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    328
    group Description
    BNP pg/mL, baseline versus end study values
    group Ids
    1. OG000
    non Inferiority Comment
    P-values and confidence intervals are not adjusted for multiple testing
    non Inferiority Type
    OTHER
    p Value
    0.035
    param Type
    Mean outcome change
    param Value
    171
    statistical Comment
    degrees of freedom = 12
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    14.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    328
    group Description
    BNP pg/mL, baseline versus end study values
    group Ids
    1. OG000
    non Inferiority Comment
    P-values and confidence intervals are not adjusted for multiple testing
    non Inferiority Type
    OTHER
    p Value
    0.035
    param Type
    Mean outcome change
    param Value
    171
    statistical Comment
    degrees of freedom = 12
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        703
        value
        883
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 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
Analysis is limited to the patients with predominant amyloid heart involvement at enrollment. Mixed models analyses of change from baseline levels of cardiac biomarkers (BNP, Troponin I) were performed to include all collected data.
reporting Status
POSTED
time Frame
12 months
title
Amyloid Cardiomyopathy: BNP
type
PRIMARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice