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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
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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
Start Date
August 1, 2021
Primary Completion Date
September 30, 2021
Completion Date
December 31, 2021
Last Updated
January 20, 2025
2,376
ACTUAL participants
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT01143454
NCT07207811
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05836259