Leiderdorp

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

This trial investigates adults aged 45 to 80 with elevated Lipoproteina Lpa levels, who either have existing cardiovascular disease or are at risk for a first cardiovascular event. The study aims to evaluate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the coronary arteries using Coronary Computed Tomography Angiography CCTA. Lipoproteina is a protein carrying cholesterol and is linked to higher heart disease risk. Participants are randomly assigned to receive either lepodisiran or a placebo through subcutaneous injections. The study lasts about 120 weeks, with primary evaluation of changes in noncalcified plaque volume at baseline and at week 104. Secondary measures include changes in fat attenuation index scores, Lpa levels over time, participant feedback on drug administration, and pharmacokinetic analysis. Throughout the study, participants will undergo imaging assessments, blood tests to monitor Lpa levels, and questionnaires regarding treatment experience. The main outcome is the percent change in noncalcified plaque volume in heart vessels. The study includes safety monitoring and continues follow-up to assess effects comprehensively over the study period.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating chemotherapy dosing strategies in older patients aged 70 years and above who have metastatic colorectal cancer and are eligible for first-line palliative chemotherapy. This phase III randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy, focusing on progression-free survival PFS. Patients are assessed using the Geriatric 8 G8 questionnaire to determine their risk of chemotherapy toxicity, which guides treatment assignment. The study seeks to balance treatment effectiveness with minimizing toxicity, hospital admissions, and maintaining quality of life QoL and physical functioning. Participants classified as low risk for toxicity G8 score 15 or higher are randomized to receive either doublet chemotherapy a fluoropyrimidine combined with oxaliplatin at full dose or with a 25% dose reduction upfront. Those at high risk G8 score 14 or lower or judged high risk by their oncologist receive fluoropyrimidine monotherapy either at full dose or with a 25% dose reduction. The study also allows the addition of targeted treatments like bevacizumab or EGFR inhibitors. Dose adjustments are made for patients with moderate kidney impairment. Chemotherapy is given orally or intravenously on schedules varying between every two and three weeks, depending on the regimen. Participants will be closely monitored throughout treatment, with assessments including radiological or clinical evaluations for disease progression, quality of life and physical functioning questionnaires at 1, 3, 6, and 12 months, and tracking of chemotherapy toxicity, overall survival, treatment cycles, dose changes, hospital admissions, and cumulative drug dosage. Safety and cost-effectiveness will also be evaluated over an average study duration of eight months and up to one year for some outcomes. The study plans to include 587 patients and will continue until December 2028.

Acute urinary retention AUR is a sudden and painful condition where a man cannot urinate, often caused by an enlarged prostate known as benign prostatic hyperplasia BPH. Treatment usually starts with inserting a catheter to empty the bladder and taking medication called alpha-blockers. This study compares two different lengths of catheter use before trying to urinate again, known as the Trial Without Catheter TWOC, to find out if a shorter catheter period is as effective and safe as a longer one. The trial includes 478 men with AUR who all receive a catheter and start or continue alpha-blocker treatment. Participants are randomly assigned to have the catheter removed either after three days or after fourteen days. The study examines if the shorter catheter duration works as well as the longer one in allowing normal urination without needing catheter replacement. It also looks at complications, patient comfort, quality of life, and healthcare costs. During the study, researchers will monitor how many men need re-catheterization after their TWOC, assess patient-reported symptoms and quality of life at multiple time points up to six months, and track complications and healthcare expenses up to 18 months after catheter insertion. The goal is to identify the best timing for catheter removal to reduce discomfort and complications and improve care. Participation lasts through these assessments and follow-ups as scheduled by the research team.

Researchers are evaluating the effects of two types of burst spinal cord stimulation SCS on pain relief and emotional aspects of pain in patients with Persistent Spinal Pain Syndrome Type 2 PSPS Type 2, also known as Failed Back Surgery Syndrome. The trial compares active recharge burst SCS versus passive recharge burst SCS, as no prior clinical studies have directly compared these two waveform methods. This randomized clinical trial aims to improve understanding of how different burst waveforms influence pain experience. The trial enrolls 96 patients across six Dutch hospitals who are randomly assigned to receive either active recharge or passive recharge burst SCS. After a successful trial period, patients will be permanently implanted with the assigned device. Active recharge burst uses negative pulses to directly compensate for charge differences, while passive recharge burst passively compensates for charge differences. Treatments are assessed over 12 months following implantation. Participants will complete various assessments including the Pain Catastrophizing Scale PCS at 6 months as the primary outcome. Secondary measures include pain ratings, patient vigilance, anxiety and depression scales, quality of life, disability index, patient global impression of change, and painDETECT questionnaires at baseline, after trial, and at 1, 3, 6, and 12 months post-implantation. The study monitors device usage and collects patient-reported outcomes to evaluate differences in pain relief and emotional response.

Researchers are investigating whether taking breaks from the standard combination therapy of daratumumab, lenalidomide, and dexamethasone Dara-Rd for newly diagnosed multiple myeloma patients affects survival and quality of life. This study aims to compare continuous treatment versus planned treatment-free intervals to see if stopping therapy temporarily may reduce side effects, allow recovery from toxicity, and improve overall well-being while controlling the disease. Participants who have completed 12 cycles of Dara-Rd with at least a partial response and no signs of disease progression will be randomly assigned to one of two groups. One group will continue Dara-Rd therapy without interruption until disease progression, while the other group will stop treatment temporarily and restart it at biochemical progression, continuing until disease progression. The trial is open-label and will follow patients for several years to assess outcomes. Throughout the study, researchers will monitor participants event-free survival and progression-free survival for up to about 57 and 69 months, respectively. Additional assessments include side effect burden, patient-reported quality of life, treatment costs, treatment-free interval length, response times, and survival after second-line therapy. Regular evaluations will help determine how treatment interruption affects toxicity, dose intensity, and overall treatment outcomes over the long term.

Researchers are evaluating whether customizing blood thinner treatment after hip or knee replacement surgery can reduce both blood clots and bleeding compared to the standard approach used for all patients. This study focuses on patients undergoing elective total hip or knee arthroplasty and aims to determine if shorter treatment is safe for low-risk patients and if higher doses for high-risk patients lower clot risks without causing too much bleeding. Participants are grouped based on their predicted risk of venous thromboembolism VTE using a risk score called TRiPplasty. Low-risk patients are randomly assigned to either a shortened prophylaxis during hospital stay only or standard treatment for about 4 weeks. High-risk patients are randomly assigned to receive intensified and extended prophylaxis for 6 weeks or standard treatment. Intermediate-risk patients participate in an observational arm without treatment changes. Treatments include types of blood thinners such as low molecular weight heparin or direct oral anticoagulants given according to Dutch guidelines. During the study, participants complete four questionnaires one before surgery, and at 2 weeks, 6 weeks, and 3 months after surgery to assess blood clots and bleeding events. An additional questionnaire at 1 year evaluates quality of life and joint function for those who experienced complications or a matched group. No extra hospital visits are required. Researchers will measure rates of venous thromboembolic events and major bleeding within 90 days, along with other health outcomes and patient-reported quality of life.