Hemse

Researchers are evaluating the optimization of treatment for patients with heart failure with reduced ejection fraction (HFrEF) using the Swedish Heart Failure Registry. The study aims to identify patients who need medication adjustments, screening and treatment for iron deficiency, referrals for heart failure devices like CRT or ICD, and referrals for physiotherapy. The goal is to improve the use of several pharmacological treatments that have shown benefits but are not yet widely implemented in clinical practice. The study involves screening 500 patients from the registry to assess their need for treatment implementation, such as starting or increasing doses of specific heart failure drugs, screening for iron deficiency, and referrals for device therapy or physiotherapy. These patients will be compared to a control group of 500 matched patients who are not enrolled in the registry screening. The intervention focuses on supporting treatment optimization based on registry data. Participants will be monitored for outcomes including the number experiencing treatment optimization events like drug initiation or dose increase, iron deficiency screening, and referrals for devices or physiotherapy. The study tracks these outcomes over one year from the index date. Researchers will collect data on drug use, device referrals, iron deficiency screening, and physiotherapy referrals to evaluate the effectiveness of registry-based screening in improving heart failure care.

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.