Clinical Research Directory

Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease

The purpose of this study, entitled "Psychological trauma, post-traumatic stress disorder, and resilience in adults with congenital heart disease in a large population sample", is to evaluate for exposures during a lifetime with congenital heart disease that may be associated with higher likelihood of developing PTSD. Primary aim: \- Identify individual patient characteristics (medical, psychosocial, socioeconomic, etc.) that are associated with a diagnosis of PTSD. Secondary aims: * Calculate the prevalence of those meeting PTSD criteria in the ACHD population using the "gold standard" diagnostic clinician interview, while using the same data to validate a PTSD screening self-report survey in the ACHD population. * Determine the role of resilience in ACHD patients using a validated screening survey to assess its protective role toward PTSD. Hypotheses: * There are certain exposures (e.g. post-surgical pain, ICU delirium, bullying due to CHD) that are associated with a higher incidence and odds of meeting PTSD criteria. * "Gold standard" diagnostic interviews will most accurately estimate the prevalence of PTSD in ACHD which has been overestimated on prior screening-based studies, although the scope of the problem is still great. * Patients with a higher resilience score will show an association with a lower risk of PTSD.

AI-Enabled Frailty Risk Prediction in Adult Congenital Heart Disease

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)

Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders

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.

Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry

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.

Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease

Several drugs have been shown effective in the treatment of obesity, with concomitant favourable cardiovascular effects. Today, there are no studies on novel anti-obesity drugs in patients with adult congenital heart disease (ACHD). Therefore, the investigators aim to study the effects of the anti-obesity drug tirzepatide (Munjaro) on cardiovascular and metabolic factors in obese patients with ACHD. In a 24-week, randomized, open-label, placebo-controlled clinical trial the investigators will compare the effects of tirzepatide versus placebo in ACHD patients diagnosed with obesity. Patients will be randomized in a 1:1 ratio to either the intervention or placebo group. Participants will have monthly visits to monitor progress. At the beginning and end of the study, a full investigation protocol will be performed.

Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease

The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).

Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease

This study aims to evaluate the real-world effects of cardiac resynchronization therapy (CRT) in adult patients with congenital heart disease (ACHD). Specifically, it seeks to determine whether CRT improves clinical outcomes in this unique patient population and to identify factors associated with a favorable response to therapy.

Observational Cohort Study of Adult Patients With Congenital Heart Disease

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.

Search for Noninvasive Markers of "Graft Injury" in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation

This clinical tissue-based, drug-free, single-center, longitudinal study aims to validate a new diagnostic method, namely, to evaluate whether plasma levels of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA), in patients undergoing orthotopic heart transplantation, can be predictive of the presence of acute myocardial rejection with the same sensitivity as immunohistochemical analysis on endomyocardial biopsy specimen, the current gold standard for the diagnosis of acute cell-mediated myocardial rejection, in a population consisting of pediatric patients and adult patients with congenital heart disease undergoing orthotopic heart transplantation.

Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD Patients?

The goal of this observational study is to compare two pre-operative methods, that is the Invasive Coronary Angiography (ICA), an actual standard diagnostic method, with the Coronary Computer Tomography (CCT) to undestand if the only CCT is sufficent to confirm the presence of a significative coronary disease and so to identify possible lesions in the coronary ematic circle, for example: stenosis and narrowing of coronary vessels. This observational study included people who have a congenital heart desease with indication of cardiac surgery and, why this disease, who had already performed these two diagnostic methods and/or who will perform them. The main question it aims to answer is: Should we avoid performing invasive coronary angiography (ICA) before cardiac surgery in people who have congenital heart desease (ACHD patients)?

Prognosis in Adult Patients With Congenital Heart Disease

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.