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Actively Recruiting

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Age: 18Years +All GendersPhase 4
52 locations
S

Actively Recruiting

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.

Age: 50Years - 99YearsAll GendersPhase 3
78 locations
T

Actively Recruiting

Researchers are studying the relationship between different levels of physical activity, sedentary time, and health outcomes in patients who have had a myocardial infarction (heart attack). The main goal is to understand how activity measured by accelerometers relates to clinical outcomes and how changes in physical activity over time affect these outcomes after a heart attack. The study plans to include about 4000 patients over two years who have experienced a myocardial infarction. Participants will wear an accelerometer device attached to their right hip during waking hours for seven consecutive days at two follow-up visits: once at 2 months and again at 1 year after hospital discharge. They will also keep a paper diary to record device wear time and working hours, then return both by mail. This process is repeated at the 1-year follow-up. During the study, participants attend follow-up visits where their physical activity data are collected and analyzed. Researchers will explore how different intensities of activity relate to major adverse cardiovascular events one year after the heart attack. Safety and adherence are monitored by collecting activity diaries and accelerometer data. Participation spans from hospital discharge through at least one year after the event to track outcomes and physical activity changes over time.

Age: 18Years - 79YearsAll Genders
35 locations
Oskarshamn Clinical Trials | DecenTrialz