Flen

Researchers are evaluating a heart failure management program that uses remote dielectric sensing ReDS technology to non-invasively assess lung congestion. The study aims to determine if this ReDS-guided program, led by nurses in primary care settings, can reduce urgent healthcare visits, unplanned hospitalizations for heart failure, and all-cause death. The trial also explores how well the program is implemented and identifies barriers and facilitators during its use. Participants are randomly assigned to one of two groups one receives usual care, and the other receives the ReDS-guided heart failure management program alongside usual care. This program uses ReDS technology to measure lung fluid levels and includes nurse-led algorithms for diuretic adjustments, a structured follow-up schedule, and support for self-care. The randomized controlled trial lasts 6 months with a 3-month focused follow-up for the primary outcome. During the study, participants will undergo assessments of urgent healthcare visits, hospitalizations, and survival at 3 months, along with evaluations of quality of life, self-care behavior, and healthcare costs. Measurements such as NT-proBNPBNP levels, ReDS values, and questionnaires on heart failure symptoms and health status are collected at baseline and during follow-up visits up to 6 months. The study also monitors how well the intervention is delivered and its reach among patients and healthcare providers.

Researchers are evaluating the effect of spironolactone combined with standard care compared to standard care alone in patients with Heart Failure with Preserved Ejection Fraction HFPEF. This condition is common and serious, but currently lacks effective treatment. The trial is a phase 3 Registry-Randomized Clinical Trial RRCT involving patients from the Swedish Heart Failure Registry and the US. HFPEF is defined by heart failure symptoms, elevated NT-proBNP levels, and an ejection fraction of 40% or higher. Participants will be randomly assigned to receive either spironolactone added to their usual care or usual care alone. Spironolactone will be given as 25 mg tablets, starting at 25 mg per day with a possible increase to 50 mg daily if tolerated. If spironolactone is not tolerated, eplerenone may be prescribed instead. The control group will continue with their standard care without spironolactone. The study duration is planned for 9 years, with enrollment lasting 7 years. During the study, researchers will collect data on cardiovascular death and hospitalizations due to heart failure as the primary outcomes. Secondary outcomes include hospitalizations for various causes, adverse events, and treatment adherence. In Sweden, outcomes will be obtained by linking national registries, while in the US, sites and call centers will report outcomes. The trial aims to enroll approximately 2000 patients, with follow-up continuing for at least 5 years after study start to monitor these outcomes.