Digital implementation strategy to increase SGLT2 inhibitor uptake in heart failure: Study design of EMAIL-HF

The EMAIL-HF trial aims to evaluate whether a digital guideline implementation strategy can increase and accelerate initiation of sodium-glucose co-transporter 2 (SGLT2) inhibitors in patients with heart failure (HF).

EMAIL-HF is a pragmatic, registry-based, randomized controlled trial including patients with a diagnosis of HF within the last 10 years, residing in the Capital Region of Denmark and the municipality of Roskilde (~2 million inhabitants). A total of 5996 eligible patients not already treated with SGLT2 inhibitors were identified from nationwide health registries and randomized 1:1 to either receive a digital letter providing information on SGLT2 inhibitors with an invitation for evaluation (intervention group: 2979 patients), or to usual care without the letter (control group: 3017 patients). The median age was 73 years (intervention) vs. 74 years (control), with 67.4% and 66.5% males, respectively. The primary outcome is the proportion of patients initiating SGLT2 inhibitor therapy within 6 months after randomization. The secondary outcome is a composite of time to first HF hospitalization or all-cause mortality. Additional exploratory outcomes include adherence, clinical events, healthcare utilization and subgroup analyses. Full baseline characteristics and clinical outcomes will be reported after completion of event accrual.

EMAIL-HF will determine whether a population-wide digital strategy can increase and accelerate guideline-based initiation of SGLT2 inhibitors in patients with chronic HF. This trial may offer a scalable model to improve implementation of novel therapies in routine clinical practice.