Ljungby

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

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.

Researchers are studying whether adding metformin to standard care can reduce the risk of major cardiovascular events in patients who have had an acute myocardial infarction and were newly diagnosed with prediabetes. This phase 3 randomized registry-based clinical trial (R-RCT) includes adult patients aged 18 to 80 years with prediabetes identified by specific blood sugar tests. The trial aims to address the gap in knowledge about metformin's effects on heart-related outcomes beyond its known role in delaying diabetes progression. Participants will be randomly assigned to two groups: one receiving standard care plus metformin and the other receiving standard care alone. Standard care includes diet and lifestyle advice following national guidelines but excludes metformin. The metformin dose will be individually adjusted up to 2000 mg daily based on how well patients tolerate it. The study is linked to the SWEDEHEART registry, which collects baseline and follow-up data. Patients will be monitored through routine care visits at 2 and 12 months after their heart attack, with a final study visit at 24 months. Laboratory tests and reports of serious adverse events will be collected yearly. Researchers will track major cardiovascular events such as death from any cause, myocardial infarction, heart failure, and stroke over an estimated follow-up of 1 to 4 years by linking registry and national health data. In total, about 5150 patients are expected to participate.

Researchers are evaluating whether remote video exercise-based cardiac rehabilitation (exCR) can increase participation in rehabilitation sessions after a myocardial infarction (heart attack), compared to traditional center-based exCR. The study is designed as a national multicenter registry-based cluster randomized crossover clinical trial, preceded by a feasibility and safety study conducted during the COVID-19 pandemic. Patients diagnosed with type 1 myocardial infarction and aged 18 to 79 years are included, with long-term follow-up planned at 1 and 3 years after the cardiac event. The study involves two phases: first, a feasibility study offering remote exCR at participating sites until the pandemic peak subsides, ending in August 2022; second, a randomized trial where cardiac rehabilitation centers are assigned to provide either remote exCR, usual center-based exCR, or a combination based on patient preference at intervention sites, while control sites offer only center-based exCR. The exercise program is standardized, requiring at least 24 supervised sessions over 3 to 4 months, each session including aerobic exercise and strength training at specified intensity levels. Success is defined as attending at least 75% of sessions within four months. Participants will be monitored through their attendance and adherence to the exercise sessions. Researchers will assess the average number of exCR sessions completed over 3 to 4 months. Additional evaluations include safety monitoring and long-term follow-up at 1 and 3 years to observe outcomes after the initial cardiac event. The study also considers patient access to internet for remote participation and evaluates exercise test results to ensure safety during rehabilitation.

Researchers are evaluating the Scandinavian guidelines designed to manage children with mild and moderate head injuries who visit emergency departments in Sweden and Norway. The study aims to determine how sensitive these guidelines are in identifying important patient outcomes, such as serious brain injuries, without introducing any new treatments. This observational study includes children under 18 years old who have suffered blunt head trauma within 24 hours and seeks to improve the accuracy of decision-making tools used in emergency care. Participants will be managed according to their hospital's usual care practices without any changes or experimental treatments. Doctors and nurses will collect detailed information about each child's injury, symptoms, and treatment in a web-based case report form. In some centers, a sub-study will collect blood and saliva samples within 12 hours of injury to analyze biomarkers that might predict brain injury. CT scans, when performed, will be reviewed by certified radiologists. During the study, follow-up information will be gathered from medical records and questionnaires sent to guardians at 1, 3, and 4 months after the injury, with additional long-term follow-up after 6 months. Researchers will track outcomes like the number of children with serious brain injuries within one week of trauma. Data will be analyzed statistically to assess how well the guidelines predict important outcomes and to explore the potential of biomarkers to reduce unnecessary CT scans. The study plans to enroll up to 5,300 children over about four years.