The Contribution of Digital Remote Monitoring to Improving the Effectiveness of Treatment in Patients with Chronic Heart Failure with Reduced Ejection Fraction: data after a 6-week follow-up period (Preprint)

BACKGROUND The main strategy for the management of heart failure (HF) patients with reduced ejection fraction is guideline-directed medical therapy (GDMT). Remote GDMT optimization using digital monitoring and guideline support appears to be a promising method. Therefore, the Contribution of Digital Remote Monitoring to Improving the Effectiveness of Treatment in Patients with Chronic Heart Failure with Reduced Ejection Fraction (BOT-IMPROVE-HF) was conducted. OBJECTIVE The aim of the study is to assess the effectiveness of rapid titration of GDMT to reach the target doses and reduce the combined endpoint of all-cause mortality and HF decompensation. METHODS This research introduces a multifaceted approach consisting of the following components: vital signs data sharing using a questionnaire via a free mobile messaging tool (chatbot), and weekly digital guideline recommendations to optimize therapy weekly for 6 weeks. RESULTS A total of 66 patients with HF with reduced ejection fraction were randomized between the remote monitoring (RM) group and the usual care (UC) group between 27 October 2023 and 27 December 2024. Thirty-three patients were included in each group. Twenty-six patients in the RM group and all patients in the UC group completed the 6-week follow-up period and were taken for primary endpoint analysis. There was a significant increase in the median dose of GDMT in the RM group, while there were no changes or were down-titrations in the UC group [angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor–neprilysin inhibitors P < 0.001*); β-blockers (P = 0.0001*); mineralocorticoid receptor antagonists (P = 0.005*)]. The doses of diuretics were significantly reduced in the RM group (P = 0.01*) and did not change in the UC group after 6 weeks (P = 0.9). HF decompensation and mortality rates were higher in the UC group than in the RM group (16 (2 mortality, 14 decompensations) vs 2 (0 mortality, 2 decompensations), P = 0.0003*). No difference was observed between the RM group and the UC group after 6 weeks in systolic blood pressure (P = 0.9), heart rate (P = 0.06), estimated glomerular filtration rate (P = 0.22) and potassium level (P = 0.33). CONCLUSIONS The article shows the results of a 6-week follow-up period. The BOT-IMPROVE-HF trial met its primary outcome and achieved a higher dose of GDMT in the RM group. The intervention was safe, and no treatment complications were registered. CLINICALTRIAL ClinicalTrials.gov NCT06304753