The EXCEED-HF study will assess if an extended remote monitoring intervention reduces worsening heart failure episodes and mortality within 180 days in patients receiving standard care.
Does an extended remote monitoring intervention reduce mortality and worsening heart failure events in patients with recent worsening heart failure?
The EXCEED-HF study is designed to evaluate whether a multimodal extended remote monitoring intervention reduces mortality and worsening heart failure events in patients with recent worsening heart failure.
Absolute Event Rate: 0% vs 0%
Abstract Aims 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. Methods A single-center, 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. Conclusion 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. Trial registration number: NL-OMON51343.
Maarschalkerwaart et al. (Fri,) reported a other. The EXCEED-HF study will assess if an extended remote monitoring intervention reduces worsening heart failure episodes and mortality within 180 days in patients receiving standard care.