Hemse

Researchers are evaluating ways to improve treatment for patients with heart failure with reduced ejection fraction HFrEF, a condition where the heart does not pump blood effectively. The study aims to identify patients who need better medication management, screening and treatment for iron deficiency, consideration for heart devices like CRT or ICD, and referral to physiotherapy. This project uses the Swedish Heart Failure Registry to find patients who may benefit from these interventions and compares outcomes to a similar group not receiving this screening. The study involves screening 500 patients enrolled in the registry to check if they need starting or increasing heart failure medications, iron deficiency screening, device therapy, or physiotherapy referrals. These patients outcomes will be compared to 500 control patients not enrolled in the registry and not receiving this targeted screening. Treatments assessed include drug initiation or dose increases for several heart failure medications and referrals for device therapy and physiotherapy. Participants will be monitored for one year from the start of the intervention or from the index date for controls. Researchers will track how many patients experience treatment optimization events, including medication changes, device referrals, and iron deficiency screening. Data on referrals for physiotherapy will also be collected. The study ensures participants can give informed consent and monitors safety and adherence throughout the study period ending in June 2026.

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.