Grosseto

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.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

The trial investigates the outcomes of Complete Mesocolic Excision with Central Vascular Ligation (CME+CVL) compared to standard right hemicolectomy without CME in patients with stage II to IV right or proximal transverse colon cancer. The purpose is to evaluate disease-free survival as the primary outcome, along with safety, cancer-related results, surgical quality, and quality of life as secondary outcomes. This is a randomized controlled trial conducted in Italy involving adult patients with right colon cancer who require surgery. Patients will be randomly assigned in equal numbers to either the CME+CVL surgery group or the standard non-CME right colectomy group. The CME+CVL surgery involves precise removal of lymphovascular tissue and vessels at their origins while preserving intact mesocolon coverage. The standard surgery involves vessel transection near the superior mesenteric vessels without extensive clearing. Surgical approaches can be open, laparoscopic, or robotic, with choices about anastomosis and drain placement left to the surgeon. Participants will be followed for a total of five years after surgery, with evaluations at 1, 4, 12, 24, 36, and 60 months. Data collected will include demographic information, perioperative and postoperative characteristics, oncologic outcomes, safety measures, and quality of life assessments. The primary outcome measured is disease-free survival at three years. The study plans to recruit 416 patients over one and a half years and continue follow-up for five years, totaling about six and a half years of study duration.

Researchers are evaluating the clinical characteristics and procedural efficacy and safety of different permanent cardiac pacing implantation approaches in patients over 18 years old who need a pacemaker or intracardiac defibrillator. The study focuses on various pacing methods including right chamber endocardial pacing, epicardial pacing, cardiac resynchronization therapy (CRT), conduction system pacing (CSP), and leadless pacing. The study aims to understand how these methods affect patient survival and quality of life, as well as the potential benefits of non-fluoroscopic anatomical and electrophysiological systems during implantation. Participants will receive permanent cardiac pacing devices according to European Society of Cardiology guidelines. The pacing types studied include conventional right ventricular pacing, conduction system pacing (such as His bundle and left bundle branch area pacing), CRT involving biventricular or left ventricular pacing, epicardial pacing, and leadless pacing. The study will observe the safety and effectiveness of these modalities at 30 days, 6 months, and 12 months, considering factors like stable electrical parameters, absence of hospitalizations, and device-related complications. During the study, researchers will collect clinical and procedural data from patients who have undergone device implantation at participating centers over a 10-year period, with an equal follow-up duration. Assessments will include monitoring device function, hospitalizations for heart failure, all-cause mortality, heart failure occurrence, and arrhythmias. Safety evaluations will track procedural complications, infections, and need for re-intervention. This comprehensive data collection aims to improve understanding of pacing methods and their impact on patient outcomes.

Researchers are evaluating the use of Percutaneous Stellate Ganglion Block (PSGB) in patients experiencing arrhythmic storm, a serious emergency condition involving multiple sustained ventricular arrhythmias in 24 hours that do not respond to standard antiarrhythmic drugs. This international multicenter observational study, coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, aims to assess the safety and effectiveness of PSGB, which has limited large-scale evidence despite growing interest in neuromodulation treatments. Patients who meet the criteria will receive PSGB using one of two common approaches: the anatomical method, which targets Chassaignac's tubercle as the needle insertion point, or the echo-guided method. Depending on patient needs, the doctor may perform either a single injection of anesthetic or a continuous infusion via a catheter connected to a pump. This short-term study observes patients for 24 hours around the procedure. Participants’ arrhythmic episodes and the number of defibrillations will be recorded before and after PSGB to measure reduction in arrhythmic relapses within 12 hours post-procedure compared to 12 hours prior. Researchers will also track complications such as hematomas, vascular or nerve damage, and anesthetic side effects. Data will be collected electronically, and the study will monitor safety and effectiveness outcomes over time, potentially enrolling around 33 patients at the main center with expansion to other sites.

Researchers are evaluating a structured multidisciplinary approach called iABC to improve the management of elderly patients with atrial fibrillation (AF) who have multiple other health conditions. This study aims to provide clear evidence that this integrated approach can improve clinical outcomes and quality of life compared to usual care. The research is conducted in Bulgaria, Denmark, Italy, Romania, Serbia, and Spain and focuses on patients aged 65 years and older with AF and multimorbidity. The iABC approach follows the ABC pathway focused on three key areas: preventing stroke with anticoagulation (using optimized vitamin K antagonists or direct oral anticoagulants), better management of AF symptoms, and optimized care for related cardiovascular and non-cardiovascular conditions. The study uses a novel platform incorporating education, a healthy or functional diet and physical activity, guideline-based drug treatments, and regular reassessments. Clinical centers in each country are randomized to either implement the iABC approach or continue with usual care. Participants will be outpatients with confirmed AF and at least one additional long-term health condition such as hypertension, coronary artery disease, or diabetes. Researchers will monitor outcomes including the impact of iABC on all-cause unplanned hospitalizations over 12 months. Assessments include guideline-based diagnosis confirmation, regular follow-up, and monitoring of treatments and lifestyle changes. Safety and adherence will be evaluated throughout the study, which aims to provide holistic care improvements for this high-risk population.

Researchers are investigating the best treatment approach for patients with acute coronary syndrome (ACS) who have intermediate narrowing (40-70% diameter stenosis) in coronary arteries not responsible for the current heart event. The study compares strategies based on optical coherence tomography (OCT), a detailed imaging method identifying vulnerable plaques, against physiology-based methods like fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), and resting full-cycle ratio (RFR) that measure blood flow to guide treatment. This trial involves about 1420 ACS patients from around 40 sites worldwide and aims to clarify which method better guides intervention in these intermediate lesions. Participants are randomly assigned to one of two groups: the OCT-guided group or the physiology-guided group. In the OCT group, lesions showing specific vulnerability signs on imaging, such as thin fibrous caps and macrophage clusters, or very small minimum lumen areas, will receive treatment using a drug-eluting stent (DES). In the physiology group, treatment with DES occurs if flow measurements (iFR, RFR, or FFR) indicate significant blockage. If these criteria are not met, intervention may be deferred. Both groups use advanced devices for imaging and flow measurement to guide decisions. During the study, participants will be closely monitored for cardiac events such as cardiac death or spontaneous heart attacks related to the treated vessel over a period of 2 years, with follow-up extending to 5 years. Researchers will assess these outcomes to determine the effectiveness of each strategy. The study includes detailed imaging, physiological assessments, and clinical evaluations to track patient progress and safety throughout the trial.

Researchers are investigating the effects of pelacarsen (TQJ230) compared to a placebo in adults with atherosclerotic cardiovascular disease (ASCVD) who have high levels of lipoprotein(a) (Lp(a)) and are also receiving inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C). The study is designed as a Phase 3 randomized, double-blind, placebo-controlled, multicenter trial with a parallel group structure, followed by an open-label treatment period. The aim is to assess the efficacy, safety, and tolerability of pelacarsen in this population. Participants will receive pelacarsen or placebo as a solution for subcutaneous injection using prefilled syringes. All participants will be given background treatment with inclisiran, starting with two loading doses spaced three months apart during the run-in period. Afterward, inclisiran will be administered every six months at Month 5 and Month 11. Following the double-blind phase, an open-label treatment period will continue, allowing further evaluation of the treatments. Throughout the study, participants will undergo assessments including measurement of lipoprotein(a) levels, with the primary outcome focusing on change in log-transformed Lp(a) concentration from baseline to six months. Laboratory tests will monitor LDL-C and other relevant markers. Safety and tolerability will be tracked continually, and standard care for cardiovascular risk factors such as hypertension and diabetes will be maintained. The study includes adults aged 18 to 80 years with established ASCVD and elevated lipid levels, ensuring ongoing monitoring and evaluation of treatment effects.