Observational Cohort Study of Adult Patients With Congenital Heart Disease

NCT06769529 | Recruiting

• 1 other identifier: ACHD-BO
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adult Congenital Heart Disease

Outcome Measures

Primary Outcomes (5)

• 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

  Through study duration, an average of 10 years

• 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)

  Through study duration, an average of 10 years

• 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

  Through study duration, an average of 10 years

• 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

  Through study duration, an average of 10 years

• The manner of death

  Sudden cardiac death Heart death from heart failure Cardiac death related to surgical procedure Cardiac death related to transcatheter procedure Cardiac death from cerebrovascular event Cardiac death from endocarditis or sepsis Noncardiac neoplastic Noncardiac by renal failure Noncardiac by suicide Other noncardiac modality

  Through study duration, an average of 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Inability to obtain longitudinal data after the first follow-up performed at our Center.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gabriele Egidy Assenza, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Egidy Assenza, MD

CONTACT

+390512149072; gabriele.egidyassenza@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 11 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 10, 2025
• Study Start: April 18, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2024-11

Locations

IT (1)