Flen

Researchers are evaluating a new heart failure management program that uses Remote Dielectric Sensing (ReDS) technology to non-invasively measure lung fluid levels. This randomized controlled trial aims to determine if the ReDS-guided program can reduce urgent healthcare visits, unplanned hospitalizations for heart failure, and all-cause death. The study also investigates how well the program is implemented and identifies barriers and facilitators to its use in primary care settings. Patients diagnosed with heart failure will be randomly assigned to receive either the ReDS-guided heart failure management program plus usual care or usual care alone. The intervention lasts for three months and is led by nurses using algorithms for follow-up scheduling, diuretic adjustments, and symptom monitoring based on lung fluid levels measured by the ReDS system. Participants will be followed for six months, during which researchers will track the total number of urgent healthcare visits, hospitalizations, and deaths at three months as the primary outcome. Secondary outcomes include quality of life, self-care behaviors, and healthcare costs. The study also includes a process evaluation to assess how the program is delivered and explores the experiences of patients and healthcare professionals.

Heart failure with preserved ejection fraction (HFPEF) is a common and serious condition without effective treatment options. Researchers are evaluating whether adding spironolactone, a medication, to standard care can reduce the combined risk of cardiovascular death and hospitalizations for heart failure in patients with HFPEF. This study is a Phase 3 trial including patients from the Swedish Heart Failure Registry and the US, all having symptoms of heart failure, elevated heart-related blood markers, and an ejection fraction of 40% or higher. Participants are randomly assigned to one of two groups: one receiving spironolactone along with usual care, and the other receiving usual care alone without spironolactone. The study is designed as a registry-randomized clinical trial and will continue until 721 cardiovascular death or heart failure hospitalization events occur, with an enrollment period of 7 years and a total study duration of 9 years. Data collection in Sweden uses registry linkages, while data in the US comes from site reports and supplemented call center follow-up. During the study, researchers will monitor participants for hospitalizations due to heart failure or cardiovascular death as the primary outcome. Secondary outcomes include other hospitalizations, side effects, and how well patients follow their treatment plans. Outcomes are tracked through national registries and direct reporting, with the main data locked and analyzed five years after the study begins. Approximately 2000 patients aged 50 to 99 years will be included to achieve the event target needed for study conclusions.