High Percentage of Subjects with NYHA stage deterioration
High Percentage of Subjects with NYHA Stage Deterioration
Type of indicator
Risk
Risk Category
Safety
Golden KRI
NO
Therapeutic Area
Cardiovascular
IF Risk-Event
The subject’s NYHA stage deteriorates (worsening of fatigue, palpitations, or dyspnea/shortness of breath)
DUE TO Risk Causes
Lack of efficacy of the study drug
THEN Risk Impact MAY RESULT
Negative impact on subject safety
Risk Indicator
High Percentage of Subjects with NYHA Stage Deterioration
Metric
Percent of Subjects with NYHA Stage Deterioration
Unit
%
What level should be measured
Study, Country, Site
Comments
NYHA – New York Heart Association
Purpose
Enhance subject outcomes, optimize heart failure management, and improve quality of life for individuals with cardiovascular disease by identifying worsening NYHA functional stages that may indicate declining cardiac function.
Description
This KRI monitors the proportion of study subjects who experience a deterioration in their New York Heart Association (NYHA) functional classification. Such deterioration indicates worsening heart failure symptoms and may require clinical intervention or treatment adjustment.
Formula
(Number of Enrolled Subjects with NYHA Stage Deterioration) / (Number of Enrolled Subjects) × 100.
Suggested Thresholds - High
10%
Suggested Thresholds - Medium
5%
Associated Metric 1
Number of Enrolled Subjects
Associated Metric 2
Number of Enrolled Subjects with NYHA Stage Deterioration
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