This study utilized the blood and first morning void (FMV) urine samples from the PARALLEL-HF study (core part). The PARALLEL-HF study (core part) was a multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to assess the effect of sacubitril valsartan at a target dose of 200 mg b.i.d. and enalapril 10 mg b.i.d. on cardiovascular (CV) mortality and morbidity in Japanese HF patients with reduced ejection fraction.
Study Type
OBSERVATIONAL
Enrollment
236
Novartis Investigative SIte
Tokyo, Tokyo, Japan
association between change in NYHA classification and change in plasma log BNP levels from Baseline
In this study, response variable change from Baseline in NYHA class was grouped into 3 categories: improved=3 unchanged=2 and worsened=1. An ordinal logistic regression model was used to assess the relationship between change from Baseline in NYHA classification and log-transformed change from Baseline of (BNP).
Time frame: Baseline, Month 6, Week 0, Week 4 and Week 8
association between the change in NYHA classification and log-transformed biomarkers from Baseline to pre-defined time points in patients treated with either sacubitril valsartan or enalapril
The response variable was the change from baseline in NYHA class (expressed as improved, unchanged, worsened). The model included baseline NYHA class as fixed effects and log-transformed change from baseline of biomarkers (BNP, cGMP, UACR, aldosterone, hsTnT, Cys-C, PRA, NT-proBNP, hsCRP) at any scheduled timepoints as covariates.
Time frame: Week 0, Week 4, Week 8, Month 6
association between the change in KCCQ-CSS and log-transformed biomarkers from Baseline to pre-defined time points in patients treated with either sacubitril valsartan or enalapril
The binary response analysis was performed using a generalized mixed model with baseline KCCQ-CSS as fixed effects and log-transformed change from baseline of biomarkers (BNP, cGMP, UACR, aldosterone, hsTnT, Cys-C, PRA, NT-proBNP, hsCRP) as covariates.
Time frame: Week 0, Week 4, Week 8, Month 6
association between the change in NYHA classification from Baseline to pre-defined time points and Baseline of log-transformed biomarkers in patients treated with either sacubitril valsartan or enalapril.
The response variable is the change from baseline in NYHA class (expressed as improved, unchanged, worsened). The model includes baseline NYHA class as fixed effects and log-transformed baseline of biomarkers (BNP, cGMP, UACR, aldosterone, hsTnT, Cys-C, PRA, NT-proBNP, hsCRP) at any scheduled timepoints as covariates.
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Time frame: Week 0, Week 4, Week 8, Month 6
association between the change in KCCQ from Baseline to pre-defined time points and Baseline of log-transformed biomarkers in patients treated with either sacubitril valsartan or enalapril.
The binary response analysis is performed using a generalized mixed model with baseline KCCQ-OSS as fixed effects and log-transformed baseline of biomarkers (BNP, cGMP, UACR, aldosterone, hsTNT, Cys-C, PRA, NT-proBNP, hsCRP) as covariates
Time frame: Week 0, Week 4, Week 8, Month 6
change in log-transformed biomarkers from baseline to pre-defined time points
Time frame: Week 0, Week 4, Week 8, Month 6