Extended and comprehensive e-Health modalities to improve outcome in patients with worsened heart failure: design and rationale of the EXCEED-HF study

Remote monitoring (RM) strategies, such as telemonitoring and nurse-guided home care, aim to detect worsening heart failure (WHF) events early on to prevent hospitalization. Previous studies on RM strategies demonstrated benefits, but they were conducted before the widespread adoption of contemporary heart failure (HF) therapies. The EXCEED-HF study, which we present in this manuscript, evaluates whether an extended RM intervention—combining telemonitoring, nurse-guided care, and a digital communication platform—reduces WHF episodes and mortality within 180 days in patients with recent WHF.

A single-centre, open-label, randomized controlled trial in patients aged >18 years with chronic or newly diagnosed HF, treated with intravenous diuretics within the past 7 days. A total of 244 patients will be randomized in a 1:1 ratio to receive either the extended RM intervention additional to standard of care (SoC) or SoC alone. The extended RM intervention consists of a combination of telemonitoring, nurse-guided home care, and a multidisciplinary digital communication platform. Primary endpoint is time to all-cause mortality or WHF episode at 180 days. Secondary endpoints include the total number of WHF events, all-cause hospitalizations, quality of life, medication adherence, caregiver satisfaction, and cost-effectiveness at 180 days. Cox proportional hazards and Poisson regression will be used for primary endpoint analyses, following intention-to-treat principles. Sensitivity analyses will include per-protocol assessment.

EXCEED-HF evaluates whether a multimodal extended RM intervention additional to SoC reduces mortality and WHF events within the context of contemporary guideline-directed HF therapy.

NL-OMON51343.