Observational Cohort Study of Adult Patients With Congenital Heart Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with congenital heart disease in natural history or previously undergoing palliative or corrective surgery in the time period after 14/02/2014

Obtaining informed consent

Disqualifiers

Age < 18 years

Inability to obtain longitudinal data after the first follow-up performed at our Center.

Trial population

The population of this study includes all patients with congenital heart disease and age older than 18 years, referred to our Pediatric Cardiology Center from 14 February 2014 to 01 May 2025 going to represent one for a cohort of about 2000 patients.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Patient's medical history and diagnosis

Anthropometric data (age, sex, weight, height, body surface area) Detailed cardiologic diagnosis classified according to anatomic complexity Presence of univentricular physiology The presence of a genetic syndrome, or reasonable suspicion of its presence Major comorbidities The surgical and interventional cardiology history The level of urgency of admission to the department and the hemodynamics room Pregnancies prior to the visit The physiologic status Sinus rhythm Therapy

Time frame
Through study duration, an average of 10 years
2

Clinical events

History of syncope since first evaluation History of NYHA III/IV since first evaluation History of moderate-grade left ventricular dysfunction History of severe grade left ventricular dysfunction Cyanosis History of cerebrovascular events (stroke/transient ischemic attack) History of endocarditis History of ventricular arrhythmias that required medical intervention History of supraventricular arrhythmias that required medical intervention Pace-Maker Implantation Implantation of Defibrillator (ICD) Implantation of Defibrillator-Resynchronizer (ICD-CRT)

Time frame
Through study duration, an average of 10 years
3

Patient visits, diagnostic tests, hospitalizations, and interventions

Longitudinal clinical evaluations Longitudinal advanced imaging assessments Longitudinal hospitalizations oIndications for hospitalization Longitudinal transcatheter procedures Type of transcatheter procedure Longitudinal surgical procedures Type of surgical procedure

Time frame
Through study duration, an average of 10 years
4

Clinical events after cardiology evaluation

Death Ventricular arrhythmia with need for intervention Supraventricular arrhythmia with need for intervention Progression to NYHA functional class III/IV Unscheduled hospitalization Bleeding Development of pulmonary hypertension Cerebrovascular event (stroke/transient ischemic attack) Plastic bronchitis Protido-dispersing enteropathy Failure of Fontan circulation Evaluation for cardiac transplantation * Refusal for cardiac transplantation * Listing for cardiac transplantation * Endocarditis * Cardiac transplantation

Time frame
Through study duration, an average of 10 years

Secondary outcomes

Other outcomes

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