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Found 5 Actively Recruiting clinical trials

E

Actively Recruiting

Researchers are evaluating a program called EuroHeart, developed by the European Society of Cardiology (ESC), which aims to improve care for patients with common heart conditions like Acute Coronary Syndrome (ACS), heart failure, and atrial fibrillation. This observational, prospective, multicenter initiative collects standardized patient data continuously in real-world clinical settings to support ongoing quality improvement. The focus is on how well healthcare providers follow ESC quality indicators proven to improve patient outcomes, addressing gaps between research and everyday practice. The study specifically looks at the Italian implementation of EuroHeart, monitoring adherence to ESC quality indicators in clinical care. It does not involve experimental treatments but collects detailed data on the management of patients hospitalized with ACS, heart failure, or atrial fibrillation. Participants' care is tracked throughout their hospital stay and beyond, with no additional interventions imposed by the study. Participants will be followed for 12 months after enrollment. During this period, researchers will collect data on clinical events, treatment adherence, and patient status to evaluate how well ESC quality indicators are met, such as timely reperfusion for STEMI patients and appropriate medication prescriptions at discharge. This long-term follow-up supports efforts to enhance care quality and patient outcomes in cardiovascular diseases.

Age: 18Years +All Genders
57 locations
F

Actively Recruiting

Older adults face a high risk of serious respiratory infections like influenza, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus, which often cause hospitalization, death, and loss of independence. This international study focuses on people aged 60 years and older who are hospitalized with these infections to better understand how these illnesses affect their ability to perform daily activities and recover function. The goal is to provide evidence that can guide vaccination and prevention efforts to support healthier aging. Participants are hospital patients confirmed by PCR test to have one of the listed respiratory viruses, including those with co-infections. The study observes their functional dependency over time using daily living activity scores. There are no interventions or treatments tested in this study; it is observational and collects data at hospital admission and during follow-up. During the study, researchers assess participants' abilities to perform daily and instrumental activities at baseline, hospital discharge, 7 days, 3 months, and 6 months after discharge. These evaluations help measure how infection impacts independence and recovery. Follow-up phone calls at 3 and 6 months are conducted to monitor progress. The study also tracks safety and adherence to ensure accurate data collection over the study period.

Age: 60Years +All Genders
24 locations
P

Actively Recruiting

Researchers are evaluating the effectiveness of physiological ventricular pacing compared to managed ventricular pacing in preventing persistent atrial fibrillation (PeAF) in patients who have a prolonged atrioventricular interval (PR9180 ms) and need a pacemaker due to sinus node disease or paroxysmal type 1 or 2 second-degree AV block. This multicenter, prospective, randomized study uses a single-blind design with double-blind evaluation, relying on the pacemaker device's internal diagnostic algorithm for outcome assessment. The study uses CE-marked devices currently in clinical practice and involves 13 Italian clinical centers experienced in pacemaker implantation procedures. Participants are randomly assigned in a 1:1 ratio to one of two groups. The PhysioVP group receives physiological ventricular pacing by delivering a stimulus to the heart's conduction system, such as the bundle of His or left bundle branch, using a specialized delivery sheath and permanent leads. The DDD-VPA group receives managed ventricular pacing, where the right ventricular lead is implanted in the myocardial right ventricle (septum or apex) and ventricular pacing is minimized using algorithms designed to avoid right ventricular pacing. In both groups, atrial leads are placed in the right atrial appendage and connected to a standard dual-chamber pacemaker. Participants will be monitored through in-office clinical visits at 1, 12, 24, and 36 months after implantation, and by home monitoring at 6, 18, and 30 months. Researchers will use continuous 12-lead ECG recordings to determine if physiological pacing is achieved. The primary outcomes measured over 36 months include the occurrence of persistent atrial fibrillation and a clinical composite outcome. Safety and effectiveness of the pacing modes will be assessed throughout the study duration.

Age: 18Years +All GendersPhase Not Applicable
1 location
R

Actively Recruiting

Researchers are evaluating how well the DRIP score calculation and its related care strategies are followed in patients who have an ileostomy after elective colorectal surgery. This study focuses on preventing dehydration and hospital readmissions, which are common complications due to fluid loss through the ileostomy. The DRIP scoring system classifies patients into risk categories to help guide care and reduce these risks. The study is prospective and observational, involving multiple Italian colorectal surgical centers. The study observes patients from the time of ileostomy creation through a 6-month follow-up period. Care strategies include pre-discharge ostomy education, intravenous fluids at home, antidiarrheal medications, daily nursing and phone follow-ups, and outpatient visits with lab tests. Patients at medium to very high risk based on DRIP score may receive additional interventions such as home nursing and specific diets. Data on various clinical and surgical parameters, stoma care, and follow-up measures are collected. Participants will have their DRIP scores calculated and monitored throughout the study. Researchers will track adherence to the DRIP protocol items and measure readmission rates at 30, 90, and 180 days, including readmissions due to dehydration. Data collection occurs over one year, with a 6-month follow-up. The study uses a secure database to record pseudonymized patient data and aims to identify factors that predict readmission and dehydration risk to improve patient care.

Age: 18Years +All Genders
7 locations
T

Actively Recruiting

Researchers are evaluating the long-term clinical and instrumental response to Cardiac Contractility Modulation (CCM) therapy in adults with symptomatic heart failure caused by systolic left ventricular dysfunction, despite receiving optimal medical treatment. This observational cohort study includes both retrospective and prospective aspects. It aims to determine the proportion of patients who experience improvement in their New York Heart Association (NYHA) class by at least one level after 12 months, reductions in hospitalizations and emergency visits, changes in quality of life using the Minnesota Living with Heart Failure Questionnaire, walking distance improvements, and differences in NT-proBNP levels. Participants either already have or will receive the CCM device called "OPTIMIZER Smart Mini," which is implanted with leads in the heart's right ventricle and optionally the right atrium. This programmable implantable pulse generator delivers electrical impulses to improve heart function. The device is intended for patients over 18 years with symptomatic heart failure and reduced left ventricular function who have not responded sufficiently to medical therapy. The study evaluates responses following implantation, guided by preimplantation low-dose Dobutamine stress echocardiography. During the study, participants' clinical status and heart function are monitored through echocardiographic tests, quality-of-life questionnaires, and walking tests over a 12-month follow-up. Researchers track hospitalizations, emergency visits, and biomarker levels as well. The primary outcome is the change in NYHA class from enrollment to study end. Safety and effectiveness data are collected as part of participants' routine medical care, with the goal of better understanding who benefits most from CCM therapy.

Age: 18Years +All Genders
13 locations