Clinical trial NCT06784687: Evaluation of the Prevalence and Clinical Manifestation of SARS-CoV-2 Infection in a Population of Adult and Pediatric Patients With Congenital Heart Disease
Official title: Evaluation of the Prevalence and Clinical Manifestation of SARS-CoV-2 Infection in a Population of Adult and Pediatric Patients With Congenital Heart Disease Not Treated Surgically, and in a Population of Pediatric Patients With Cardiomyopathy, Arrhythmic Pathology, or Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Cardiomyopathy
Pulmonary Arterial Hypertension
SARS CoV-2 Infection
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 2376
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients followed at our center and suffering from congenital heart disease treated by hemodynamic procedures alone, as well as pediatric patients with cardiomyopathy, pulmonary hypertension, or arrhythmic disease whose follow-up was still ongoing at the time of the onset of the pandemic

Brief summary: The goal of this observational study, drug-free, cross-sectional, single-center is to describe the incidence and characteristics of the clinical course and any short- and medium-term complications of patients with congenital heart disease of medical interest, and pediatric patients with cardiomyopathy, arrhythmic pathology or pulmonary arterial hypertension who have been affected by Sars-Cov-2 disease. The secondary objective of the study is to identify risk factors for the development of moderate-severe forms of COVID-19 disease in the study population.

Detailed description: This is an observational, drug-free, cross-sectional, single-centre study. All patients followed at our centre and suffering from congenital heart disease treated with only haemodynamic procedures haemodynamic procedures alone, as well as paediatric patients suffering from cardiomyopathy, pulmonary hypertension or arrhythmic pathology whose follow-up was still in progress at the time of the start of the pandemic (due to death or for reasonsof the patient). The structural collection of data necessary for the evaluation of targets will take place through the creation of a specific electronic archive, in which census of all patients who have undergone follow-up at our centre since 01/01/2005 at the time of study approval and still in follow-up at the time of the start of the pandemic.

Patients of all ages will be enrolled age, both paediatric and adult, followed at our centre. It is estimated to include in the study approximately 5000 patients.

Eligibility criteria: Inclusion Criteria:

* Patients of all ages with congenital heart disease undergoing hemodynamic procedures at our center or in natural history
* Pediatric patients with cardiomyopathy, arrhythmic disease, or hypertension pulmonary
* Obtaining informed consent
* Patients who have access to an e-mail address and a computer to complete the questionnaire

Exclusion Criteria:

* Patients with congenital heart disease undergoing corrective or palliative surgical treatment

Primary outcomes:
measure: Severity of SARS-CoV-2 infection evaluation
timeFrame: Upon completion of the questionnaire by patient on day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Simone Bonetti, MD
role: PRINCIPAL_INVESTIGATOR
References: