Main Outcomes and Measures Primary end points were change from baseline in plasma NT-proBNP level at week 12 and in the 6-minute walk distance at week 24. Interventions Patients were randomized 1:1 either to sacubitril/valsartan (n = 1286) or to background medication–based individualized comparator (n = 1286), ie, enalapril, valsartan, or placebo stratified by prior use of a renin angiotensin system inhibitor. Of 4632 patients screened at 396 centers in 32 countries, 2572 patients with heart failure, LVEF of more than 40%, elevated NT-proBNP levels, structural heart disease, and reduced quality of life were enrolled (last follow-up, October 28, 2019).
#Parallax fitness trial#
Objective To evaluate the effect of sacubitril/valsartan on N-terminal pro–brain natriuretic peptide (NT-proBNP) levels, 6-minute walk distance, and quality of life vs background medication–based individualized comparators in patients with chronic heart failure and LVEF of more than 40%.ĭesign, Setting, and Participants A 24-week, randomized, double-blind, parallel group clinical trial (August 2017-October 2019). Importance There is limited evidence on the benefits of sacubitril/valsartan vs broader renin angiotensin system inhibitor background therapy on surrogate outcome markers, 6-minute walk distance, and quality of life in patients with heart failure and mildly reduced or preserved left ventricular ejection fraction (LVEF >40%).
Test values below lower or above the upper limit of quantification are imputed by 0.5 × the lower limit of quantification × 1.5 × upper limit of quantification.ĪCE indicates angiotensin-converting enzyme ARB, angiotensin II blocker HbA 1c, hemoglobin A 1c LVEF, left ventricular ejection fraction NYHA, New York Heart Association RAS, renin angiotensin system. The analysis includes data observed up to week 12. The mixed model for the repeated-measures model includes stratum angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), no renin angiotensin system inhibitors, region, treatment (sacubitril/valsartan, background medication–based individualized comparators), visit, treatment × visit interaction, subgroup, subgroup × visit interaction, treatment × subgroup interaction, and treatment × subgroup × visit interaction as fixed-effect factors baseline log-transformed N-terminal pro–brain natriuretic peptide (NT-proBNP), stratum × baseline log-transformed NT-proBNP, and visit × baseline log-transformed NT-proBNP interactions as covariates and models the within-patient covariance using an unstructured covariance matrix (a common matrix for the 2 treatment groups). The interaction P value is for the subgroup variable × the treatment interaction at week 12. Requests may be made directly to and every effort will be made to honor them within 48 hours.An adjusted geometric mean ratio lower than 1 favors sacubitril/valsartan. This policy allows verified trademark owners to specify: (A) that their identifiable information be masked, or (B) that their trademark pages permanently deleted from.
#Parallax fitness verification#
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