Impact of frailty on effects of antihypertensive treatment in cardiovascular disease and all-cause mortality SAP

The aim of this individual participant data (IPD) meta-analysis is to investigate whether patient frailty modifies the effect of antihypertensive treatment, using data from five landmark randomized, double-blind, placebo-controlled antihypertensive trials. This statistical analysis plan (SAP) pre-specifies the primary and secondary outcomes of the study, the analytical approach for evaluating the interaction between frailty level and antihypertensive treatment, and the key variables included in this IPD meta-analysis. The primary analysis uses trial-stratified Fine–Gray competing-risk regression models. The SAP also outlines planned sensitivity analyses, including subgroup analyses and re-analyses using a frailty index constructed after excluding cardiovascular-related items.