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NCT07546227
This study is a single center randomized controlled trial evaluating the effect of an exercise training intervention (interval training or moderate continuous training) compared to usual care (no training) on exercise capacity in patients with congenital heart disease (CHD). Our primary aim is to determine the impact of interval training (IT) compared to moderate continuous exercise training (MCT) versus controls (no exercise) on exercise capacity as measured by peak VO2. Secondary aims are to: 1) assess the safety of exercise training in CHD, 2) evaluate the effect of exercise training on cardiac structure and function and 3) assess the effects of exercise training on quality of life and long-term physical activity.
NCT07479654
The goal of this three-year mixed-methods observational study with an embedded randomized controlled trial is to develop and validate a frailty risk prediction model and evaluate an artificial intelligence-based voice emotion detection-guided counselling intervention in adults with congenital heart disease (ACHD). The main questions it aims to answer are: Are symptom clusters associated with frailty and psychological outcomes in adults with congenital heart disease? Can symptom clusters and psychosocial factors be used to predict frailty risk over time in ACHD patients? Does an AI-based voice emotion detection-guided counselling intervention improve psychological outcomes, fatigue, and quality of life among high-risk ACHD patients? Researchers will compare ACHD patients receiving AI-based voice emotion detection-guided counselling with those receiving usual care to determine whether the intervention reduces depression, anxiety, sleep disturbance, fatigue, and frailty risk, and improves grit and quality of life. Participants will: Complete longitudinal assessments of symptom clusters, frailty, and psychological status at baseline and follow-up time points Participate in qualitative interviews to explore lived experiences related to symptoms and frailty Receive AI-based voice emotion detection-guided counselling (intervention group only in Year 3)
NCT07477197
A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes.
NCT06932081
This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.
NCT06769529
The aim of this retrospective and prospective single-center observational study is to evaluate the correct management of adult patients with congenital heart diseas (ACHD), based on the experience of a reference center such as the Institute of Pediatric Cardiology at Policlinico Sant'Orsola Malpighi. The patients participating in this study will not be subjected to any procedures beyond normal daily clinical practice; likewise, the clinical variables that will be collected for the study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves naturalistic observation of current clinical practice without the application of any kind of intervention.
NCT06723704
This is a mono-center observational ambispective study in which adult patients with congenital heart disease evaluated at our institution will be enrolled. The primary endopoint is to assess the clinical and echocardiographic predictors of adverse events during follow-up (death, arrhythmias, cardiac hospitalization). The secondary endpoints are: 1) evaluation of the incidence of the singular components of the primary endpoint; 2) evaluation of the prognostic impact of acquired lesions, including valve disease not present at birth; 3) need for surgical/percutaneous interventions during follow up. Participants will be evaluated in the context of scheduled follow-up visits in our Outpatient ACHD Clinic. No interventions/drug administration will be performed other than those required by standard clinical practice.