Koping

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

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.

Researchers are investigating how different levels of physical activity, measured objectively, relate to health outcomes in patients who have had a type 1 myocardial infarction. The study aims to explore links between activities of varying intensity, sedentary time, and the risk of major cardiovascular events after a heart attack, as well as how changes in physical activity over time affect these outcomes. Participants in this observational study will be asked to wear an accelerometer device on their right hip during waking hours for seven consecutive days at two follow-up visits2 months and 1 year after hospital discharge. They will also keep a diary recording their wear time and working hours if applicable. About 4000 patients aged 18 to 79 diagnosed with myocardial infarction are expected to be included, and the study will analyze the dose-response relationship between accelerometer data and clinical outcomes. Throughout the study, participants will attend cardiac rehabilitation follow-up visits and provide accelerometer and diary data. Researchers will assess outcomes such as major adverse cardiovascular events, including heart failure, stroke, death, and coronary revascularization, at 1 and 3 years after the initial cardiac event. The study will monitor these outcomes while participants continue their usual care, with a total follow-up period extending to 3 years after the heart attack.