Trollhattan

Researchers are evaluating optimized drug treatments for patients with Takotsubo Syndrome, also known as Broken Heart Syndrome. This large Phase 4 trial aims to include 1000 patients registered in SWEDEHEART to provide documented evidence for effective pharmacologic care, as current data is limited. The study is a multinational, multicenter, registry-based, open-label, randomized controlled trial focused on improving treatment outcomes for this heart condition. Participants may receive one of several treatments: an infusion of Adenosine at 70 g/kg/min for 3 hours, oral Dipyridamole 200 mg twice daily, oral Apixaban 5 mg twice daily, or care guided by recommendations from the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology, which may vary by local practice. The trial includes two randomizations with specific treatment options and criteria. During the study, researchers will assess heart function using wall motion scores and monitor for serious events such as death, cardiac arrest, heart failure hospitalization, or reduced heart ejection fraction up to 30 days after treatment. They will also track thromboembolic events and cardiac thrombus via echocardiography within the first few days and through day 30. Safety and treatment adherence will be monitored throughout, with detailed follow-up to understand treatment effects and patient outcomes.

Out-of-hospital cardiac arrest (OHCA) often involves dangerous heart rhythms like ventricular fibrillation (VF) or ventricular tachycardia (VT), which require defibrillation to restore a normal heartbeat. Survival chances decrease the more defibrillations are needed. Recent research suggested that using Double Sequential Defibrillation (DSD), which applies two defibrillators sequentially, may improve survival in patients with refractory VF. This trial aims to evaluate if applying DSD earlier, right after the first failed defibrillation in patients with shockable rhythms, improves 30-day survival compared to standard single defibrillation. Participants will receive either the early DSD strategy, where a second defibrillator is added with electrodes placed on the chest and back (anterior-posterior position) and shocks are delivered sequentially, or the usual care involving standard defibrillation with one defibrillator and pads placed in the anterior-lateral position. The study is an open-label, randomized controlled trial with equal allocation to each group, conducted by emergency medical services equipped with two defibrillators on site. During the trial, emergency teams will screen eligible adult OHCA patients with shockable rhythms who have had at least one unsuccessful defibrillation. The main outcome measured is survival 30 days after the cardiac arrest. The trial involves initial rhythm analysis, delivery of assigned defibrillation methods, and follow-up to assess outcomes. This study could influence future advanced cardiac life support guidelines if early DSD proves beneficial for a wider group of patients.

Researchers are investigating reproductive health and related factors in adults with Fontan circulation, a type of single-ventricle heart defect circulation. This study aims to understand the prevalence and causes of sexual dysfunction and infertility, pregnancy outcomes, delivery choices, and parental experiences in this group. It also explores fatigue and cognitive function, which may impact quality of life and reproductive health in these patients. The research is conducted across six national centers in Sweden, including about 200 patients and their partners. Participants will complete questionnaires and undergo functional tests, with data collected from medical records and obstetrical documents. The study includes several sub-studies focusing on sexual health, pregnancy risks, personal experiences of parenthood, and cognitive assessments. This observational study does not involve any experimental treatments but gathers detailed information through surveys and clinical evaluations. During the study, participants will be assessed for sexual dysfunction, infertility, pregnancy complications, and cognitive abilities such as memory and attention. Researchers will analyze fatigue levels and other factors that may explain health outcomes. The main outcome measured is the prevalence and causes of sexual dysfunction and infertility, with assessments lasting approximately three hours. The study is designed to improve understanding and care for adults living with Fontan circulation.

Researchers are evaluating treatments for elderly patients aged 75 and older who have an undisplaced femoral neck fracture (uFNF), classified as Garden I-II. The study compares whether replacing the hip (arthroplasty) reduces the need for further surgeries compared to preserving the hip with internal fixation. The goal is to lower the combined risk of needing reoperation or death within 1 to 2 years after surgery. Participants are randomly assigned to one of two treatment groups using the Swedish Fracture Register. One group receives arthroplasty, which may be either a hemi or total hip replacement depending on hospital routine based on patient age and mobility. The other group undergoes internal fixation, where the fracture is repaired using 2-3 screws, pins, or a sliding hip screw device, again according to hospital routine. Both treatments are devices applied to stabilize or replace the hip after fracture. During the study, participants are monitored for outcomes including the rate of additional surgeries and mortality up to 2 years after their initial operation. The main measure combines these two outcomes into a single variable to evaluate overall treatment success. The entire process is registered and randomized within the Swedish Fracture Register system, ensuring consistent follow-up and data collection.

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.

Preterm preeclampsia is a serious condition affecting both mothers and their babies, often leading to early delivery to protect health. This trial focuses on whether metformin, a common diabetes medication, can safely extend the pregnancy duration, improve newborn weight, and reduce hospital time for babies in Nordic countries. The study builds on earlier research showing potential benefits of metformin for preterm preeclampsia and aims to confirm these findings in a larger group. Participants will receive either metformin extended release or a placebo, both taken orally three times daily. Starting with one tablet three times a day, the dose may increase to two tablets three times daily if tolerated, continuing until delivery. If side effects occur, the dose can be lowered while maintaining blinding. Participants will keep diaries to track medication use, and routine care for preeclampsia will continue without changes from the study. During the study, researchers will monitor pregnancy length from randomization to delivery, measuring how long gestation is prolonged, along with birthweight and newborn hospital stay length. Mothers and children will be followed up two years after birth. Safety, adherence to medication, and any side effects will also be closely observed throughout the trial to assess the impact of metformin on preterm preeclampsia outcomes.

Researchers are investigating the long-term management of patients with propionic aciduria (PA) and methylmalonic aciduria (MMA) who are receiving maintenance therapy with N-carbamylglutamate (NCG). This prospective, mixed-design study includes patients treated with carglumic acid for at least six months, aiming to collect detailed data on treatment characteristics, clinical outcomes, and healthcare use. Adult patients and caregivers also participate in interviews to better understand the burdens of the disease and treatment on their lives. The study will enroll up to 85 patients from six European countries who have been on carglumic acid therapy. Data will be collected at baseline, 12, 18, 36, and 54 months to observe changes over time. Participants or their caregivers who agree will also take part in a one-hour phone interview to discuss symptoms, treatment experiences, preferences, and satisfaction. All medical chart data and interview information will be securely recorded and analyzed. Participants will undergo regular assessments through medical chart reviews and interviews over a 54-month period. Researchers will monitor the number and duration of decompensation events, healthcare resource use, and patient and caregiver burden. The study will use both statistical software for data analysis and qualitative methods to capture patient experiences. Results aim to provide a comprehensive understanding of long-term treatment impacts while ensuring participant confidentiality.

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.