Ivrea

This research aims to evaluate LTP001 treatment in both healthy adults and participants with pulmonary arterial hypertension PAH. It explores safety, tolerability, and how the body processes LTP001 in healthy volunteers Part A, and assesses safety and efficacy in PAH patients Part B followed by an extended safety period. The study is designed as a randomized, double-blind, placebo-controlled trial sponsored by Novartis Pharmaceuticals. Participants in Part A receive single and multiple ascending doses of LTP001 or placebo to understand pharmacokinetics and safety over 35 days. Part B involves treatment with LTP001 or placebo alongside stable standard PAH therapies, with treatment periods up to 106 weeks including a 24-week initial evaluation and a longer safety extension. Both parts include placebo comparison and dose escalation in a parallel study model. Throughout the study, participants undergo monitoring for adverse events, changes in pulmonary vascular resistance, and functional assessments such as the Six-minute Walk Test and WHO functional class. Blood tests measure biomarkers like NT-proBNP. Safety and pharmacokinetic data are collected frequently in Part A, while Part B includes long-term efficacy and safety evaluations up to 106 weeks. Participant involvement includes regular visits for treatment administration, assessments, and follow-up until study completion in late 2028.

Researchers are evaluating a new medicine called NNC6019-0001 for people with transthyretin amyloid cardiomyopathy ATTR-CM, a condition that affects the heart and leads to heart failure. This Phase 3 study compares NNC6019-0001 with a placebo to see if it can reduce the risk of heart-related death and illness. Participants will continue their usual heart treatments throughout the study. Participants will receive either NNC6019-0001 or a matching placebo through intravenous IV infusion. Both groups may also continue their standard heart failure treatments as advised by their doctors. The study is randomized and blinded so that neither participants nor researchers know who receives the medicine or placebo. Treatment and follow-up will last up to about 4 years. During the study, participants will have regular assessments including heart function tests, questionnaires about heart failure symptoms and quality of life, and walking tests to measure physical ability. Researchers will monitor heart-related events such as hospitalizations and urgent visits for heart failure, as well as death from cardiovascular causes. Safety labs and biomarker tests will be done. The main outcome is a combination of cardiovascular deaths and recurrent heart problems measured from the start to the end of the study.

Researchers are conducting a phase III randomized clinical trial to study early stage Follicular Lymphoma, a type of lymphoma that has not been treated before. The trial compares the effects of local Radiotherapy alone versus Radiotherapy combined with the drug Obinutuzumab. The goal is to better understand how these treatments work for patients with early stage Follicular Lymphoma and to evaluate progression-free survival and other outcomes. Participants will be randomly assigned to one of two groups one group will receive involved-site Radiotherapy at a standard dose of 24Gy alone the other group will receive the same Radiotherapy followed by Obinutuzumab infusionsfour weekly doses plus four additional doses every three weeks, totaling eight doses. This open-label study is conducted across multiple centers. During the study, participants will be monitored for treatment response and side effects over a period of up to 45 months, including 9 months of treatment and 36 months of follow-up. Assessments include imaging scans, laboratory tests, and molecular analyses to evaluate response rates, disease progression, and molecular markers. Safety and adverse events will be tracked throughout, with long-term follow-up to understand treatment effects and disease status.

Researchers are evaluating the EuroHeart program, an observational and prospective multicenter initiative designed to improve quality of care for patients with common cardiovascular diseases such as Acute Coronary Syndrome ACS, heart failure, and atrial fibrillation. EuroHeart collects standardized and harmonized patient data to support continuous quality improvement by monitoring adherence to quality indicators defined by the European Society of Cardiology ESC. The program aims to understand how well proven treatments are applied in everyday clinical practice. The study involves continuous data collection from consecutive patients hospitalized or treated for these cardiovascular conditions. Participants enter a 12-month follow-up period during which clinical events and health status data are gathered. This registry specifically evaluates adherence to ESC quality indicators in Italian clinical practice, including measures such as time to reperfusion and prescription of recommended medications at discharge. Participants will be monitored through regular collection of clinical data over the 12 months following enrollment. Researchers will assess adherence to multiple ESC quality indicators related to treatment and management of STEMI and NSTEMI patients, including evaluations of left ventricular function, lipid levels, and use of dual antiplatelet therapy and other medications. The study also tracks cardiovascular and non-cardiovascular events during follow-up to support quality improvement efforts. Participation involves consent and data collection without experimental treatments.

Researchers are studying patients experiencing arrhythmic storm, a serious heart condition characterized by frequent and sustained ventricular arrhythmias that do not respond to standard antiarrhythmic drugs. This international multicenter observational study aims to evaluate the safety and effectiveness of Percutaneous Stellate Ganglion Block PSGB in reducing arrhythmic relapses in such emergency cases. The study is coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, and addresses a gap in large-scale data on this procedure. Participants who meet the criteria will receive PSGB using either the anatomical or echo-guided approach. Depending on patient needs, the procedure may involve a single anesthetic injection or continuous anesthetic infusion via a catheter connected to a pump. The study compares the number of arrhythmic events and defibrillations before and after PSGB treatment and notes any complications occurring within 12 hours post-procedure. During participation, patients will be monitored closely for arrhythmic relapses using defibrillation counts and anti-tachycardia pacing data. Complications such as hematomas, vascular injuries, and nerve damage will be recorded. Data are collected using a secure electronic system, with effectiveness measured by arrhythmic event reduction in the 12 hours following PSGB compared to the 12 hours prior. The study plans to enroll patients over several years with ongoing safety and outcome evaluations.

Researchers are conducting the RICMAF Study, an observational, multicenter, non-drug study in Italy focused on Anderson-Fabry Disease AFD, a rare genetic disorder that affects multiple organs, especially the heart. The study aims to better understand AFDs clinical course, its cardiac complications, and the relationship between genetic mutations and disease progression. This research seeks to improve patient care by identifying early markers of heart involvement and predicting cardiovascular problems. The study collects data from patients diagnosed with AFD according to international guidelines, starting from January 1, 1981, through December 31, 2031. It includes both retrospective and prospective phases, gathering comprehensive clinical, genetic, laboratory, and imaging information through a national patient registry. Patients undergo regular assessments as part of their standard care, including cardiology evaluations, ECG, echocardiography, and cardiac MRI when appropriate. Participants contribute data during routine clinical visits without additional study-specific procedures. The research team collects information from medical records and follow-up visits, including family history, symptoms, genetic tests, and heart monitoring results. The primary outcome is to define the natural history of Fabry disease over an average follow-up of five years, while secondary outcomes focus on cardiac risk stratification, genotype correlations, and early diagnostic biomarkers. The study duration extends up to 10 years, with ongoing data analysis and publication of findings.

Researchers are evaluating a cardiogenic shock protocol designed to improve communication and collaboration among hospitals to timely refer cardiogenic shock patients from spoke to hub centres in the Turin and Milan metropolitan areas. This observational study includes both a retrospective cohort from 2016 to 2019 and a prospective cohort starting in 2024. The purpose is to assess whether implementing this dedicated protocol reduces in-hospital or 30-day mortality in patients with acute myocardial infarction complicated by cardiogenic shock AMICS. Cardiogenic shock is a critical condition requiring rapid intervention and specialized care, and the study focuses on improving outcomes by optimizing patient transfer and treatment coordination. The study compares two groups one retrospective group of patients admitted before the protocol was implemented, and one prospective group admitted after the protocol adoption. Patients in the prospective cohort are managed under a standardized communication and referral protocol between spoke and hub centres, which include advanced cardiac interventions such as percutaneous mechanical circulatory support and prompt transfer to specialized teams. Hub centres have multidisciplinary shock teams, cardiac surgery backup, and 247 availability of cardiac care services. Spoke centres provide initial care and stabilization. The study involves 16 centres, with four hubs each receiving patients from three spoke centres. Participants will be monitored during their hospital stay and followed up to 30 days from admission. Data collected include clinical characteristics, treatments, timing of mechanical support device insertion, adverse events, and outcomes like mortality, stroke, bleeding, renal replacement therapy, vascular complications, and myocardial infarction. The study uses electronic health records and prospectively collected data, with no changes to standard care. The primary measure is 30-day mortality, and secondary outcomes include various clinical events and timing metrics related to treatment support. The study aims to provide insight into whether the hub-and-spoke protocol improves survival and quality of care for cardiogenic shock patients.

Researchers are creating a large registry of patients with ATTR amyloidosis to better understand the diseases natural history in a real-world setting. This study aims to collect data from diagnosis and during follow-up to develop and validate models that predict outcomes and response criteria at any stage of the disease. The registry also promotes data sharing and collaboration among amyloidosis experts and physicians nationwide, improving diagnosis and management of systemic amyloidosis. The study involves an online registry tool accessible to healthcare providers, facilitating data entry and sharing. This network allows physicians to request diagnostic support from the Amyloidosis Research and Treatment Center ARTC, enhancing patient care through expert collaboration. The registry collects ongoing data during patient follow-up at participating centers. Participants contribute by allowing their clinical data to be included in the registry, either prospectively or retrospectively if they have given informed consent. Researchers will monitor the establishment and use of the online data-sharing tool over five years. The study does not involve experimental treatments but focuses on observation and data collection to improve understanding and management of ATTR amyloidosis.