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Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

This trial studies men with low-volume, hormone-sensitive metastatic prostate cancer to evaluate if a shorter treatment duration with androgen receptor pathway inhibitors (ARPIs) like Apalutamide or Enzalutamide is as effective as continuous therapy. The purpose is to see if stopping ARPI treatment after 12 months, with the option to restart if the cancer progresses, can reduce side effects and costs without worsening outcomes. This is a Phase 3 randomized nationwide study focusing on patients with low-volume metastatic disease confirmed by imaging and clinical assessment. Participants will receive androgen deprivation therapy (ADT) combined with either continuous ARPI treatment or ARPI treatment stopped at 12 months. Those who stop ARPI after 12 months may restart treatment if their PSA levels rise, confirmed by a second test at least 4 weeks later. The study compares these two approaches to understand if shorter ARPI use is non-inferior to continuous use, aiming to reduce treatment toxicity while maintaining disease control. Participants will be followed for up to 6 years, with clinical progression-free survival as the main outcome. Researchers will monitor time from study inclusion to disease progression or treatment end. Patients will undergo regular assessments including PSA testing and clinical evaluations to track disease status. Safety and treatment effects will be closely observed throughout the study period, which includes up to 5 years of active follow-up after randomization.

Researchers are evaluating chemotherapy dosing strategies for older patients aged 70 years and above who have metastatic colorectal cancer and are candidates for palliative chemotherapy. This phase III, open-label, randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy to see if the reduced dose is not worse in terms of progression-free survival (PFS). The study also examines secondary outcomes including severe toxicity, quality of life, physical function, overall survival, treatment cycles, dose reductions, hospital admissions, cumulative dosage, and cost-effectiveness. Participants are classified based on their risk of chemotherapy toxicity using the Geriatric 8 (G8) questionnaire. Those at low risk are randomized to receive either full-dose or 25% dose-reduced doublet chemotherapy (a fluoropyrimidine combined with oxaliplatin). Patients at high risk receive either full-dose or dose-reduced monotherapy with a fluoropyrimidine. Targeted treatments like bevacizumab or EGFR inhibitors may be added. Dose adjustments are made for moderate kidney impairment. Treatments are given on schedules involving oral and intravenous chemotherapy drugs administered every 2 to 3 weeks. During the study, participants undergo assessments including clinical evaluations, laboratory tests to monitor blood counts and organ function, and questionnaires for quality of life and physical functioning. Progression-free survival is tracked for at least one year after randomization. Researchers closely monitor treatment toxicity, hospitalizations, dose modifications, and survival. The total planned enrollment is 587 patients, with follow-up for safety and effectiveness throughout the treatment period.

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.

Researchers are investigating the treatment of multiple myeloma using a combination of medicines called daratumumab-lenalidomide-dexamethasone (Dara-Rd). This standard treatment in the Netherlands often suppresses the disease for a long time and continues until it stops being effective. The study aims to find out if stopping treatment temporarily, compared to continuing it without breaks, can improve quality of life by reducing side effects and allowing recovery from toxicity, without reducing survival time. The study involves patients who have completed 12 cycles of Dara-Rd treatment and have responded with at least a partial response without biochemical progression. These patients will be randomly assigned to either continue Dara-Rd treatment continuously or take a treatment-free interval. The medications involved include daratumumab injections, lenalidomide capsules, and dexamethasone. Reduced dosing of lenalidomide is allowed but not below 5 mg, and prior dexamethasone dose changes are permitted. The trial is a nationwide, open-label, randomized Phase III study. Participants will be followed for up to approximately 57 months to compare event-free survival and up to 69 months to compare progression-free survival after randomization. Researchers will monitor disease status, side effects, and overall health during this time. Patients must provide informed consent and will undergo regular assessments to evaluate the impact of continuous versus interrupted therapy on their disease and quality of life.

Researchers are studying the changes and characteristics of the gut microbiome during chemotherapy in patients with metastatic or irresectable colorectal cancer (CRC). The study aims to explore how the gut microbiome relates to the effects of chemotherapy, as current treatments have limited overall survival and significant side effects. Understanding the microbiome could help improve treatment selection and effectiveness for CRC patients undergoing systemic anti-tumor therapy. Participants will collect fecal samples at home before starting treatment and three months after treatment begins, coinciding with response evaluations. They will also fill out questionnaires about factors that might affect the microbiome, such as antibiotic or proton pump inhibitor use. Additionally, blood samples will be collected before treatment and three months later for storage and analysis. Treatments include any combination of chemotherapy with or without anti-VEGF or anti-EGFR therapy. During the study, researchers will monitor changes in the gut microbiome and evaluate the patients' response to chemotherapy over two years. Outcome measures include prediction of response to conventional systemic anti-tumor therapy. Participants must provide informed consent and comply with study procedures, including sample collection and questionnaires. The study focuses on improving understanding of the microbiome's role in treatment outcomes and safety in metastatic or irresectable CRC.

This research aims to evaluate the effects of testosterone replacement therapy (TRT) on sexual function and cancer outcomes in men with testosterone deficiency who have undergone radical prostatectomy (RP) for non-metastatic prostate cancer. Sexual dysfunction is a common side effect of RP and negatively impacts quality of life, especially in older men who often experience declining testosterone levels. The study is a phase 3, randomized, placebo-controlled, single-blind trial focused on men diagnosed with prostate cancer and scheduled for RP. Participants will be randomly assigned to receive either a daily topical testosterone gel or a placebo gel starting within 8 weeks after their RP. Treatment will continue for one year. Testosterone levels will be measured before and after surgery to determine eligibility and monitor therapy. After the treatment year, participants will be followed for an additional year to assess functional outcomes, and for up to five years to evaluate cancer recurrence rates. During the study, participants will undergo routine blood tests, complete online questionnaires, and attend follow-up visits similar to standard care after RP, with some additional blood samples early in the study. Researchers will assess sexual functioning using the EPIC-26 questionnaire, urinary continence, hormonal function, and biochemical recurrence-free survival. Safety monitoring includes observing for local skin reactions and systemic side effects related to testosterone therapy. The total follow-up period extends up to five years after surgery to thoroughly evaluate outcomes.

Researchers are investigating the effectiveness of adding liothyronine (LT3) to levothyroxine (LT4) treatment in patients with autoimmune hypothyroidism who continue to experience significant tiredness despite normalized thyroid hormone levels on LT4 alone. This phase 3 trial addresses the issue that LT4 monotherapy may not achieve the natural balance of thyroid hormones, as some patients still feel tired. The study also explores genetic factors that might influence treatment response. The study begins with a run-in period where all participants switch to a standardized LT4 preparation to stabilize thyroid hormone levels. During this 4-8 month period, doses are adjusted to maintain normal TSH levels, and patients with unstable TSH or heart abnormalities are excluded. Those with persistent tiredness and stable hormone levels then enter a 1-year double-blind randomized trial, receiving either LT4 combined with LT3 or LT4 with placebo. Regular visits occur at baseline and weeks 8, 16, 26, 39, and 52, including dose adjustments and comprehensive assessments. Participants complete questionnaires about tiredness, quality of life, and medical resource use at every visit. Additional blood tests for genetics and thyroid metabolites occur at baseline and 52 weeks, along with monitoring of bone, cardiovascular, metabolic, and brain health through scans, ECGs, and neurocognitive tests in subgroups. The main outcome is the change in tiredness scores over 52 weeks, with safety and treatment effects closely monitored throughout the study.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

Researchers are comparing two diagnostic approaches for patients suspected of having muscle-invasive bladder cancer. The study evaluates progression-free survival over two years, the time to definitive treatment, and cost-effectiveness between the standard care method of transurethral resection of the bladder tumor (TURBT) and a newer approach using multi-parametric MRI (mpMRI) followed by a same-day cystoscopic bladder biopsy. This is a two-arm multicenter randomized controlled trial aiming to improve local staging methods for this condition. Participants will be randomly assigned to one of two groups. One group will receive the standard of care involving TURBT along with blood samples taken shortly before and after the procedure. The other group will undergo mpMRI followed by a cystoscopic bladder biopsy on the same day. These procedures are designed to assess and diagnose the suspected muscle-invasive bladder cancer more precisely. During the study, participants will be monitored for progression-free survival for up to two years. Researchers will collect data on how long patients remain free from disease progression, the timing of definitive treatments, and overall cost-effectiveness. The trial involves multiple centers, and participants will provide written informed consent before enrollment. This study focuses on adults suspected of muscle-invasive bladder cancer without evidence of lymph node or distant metastases.