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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

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Completed

Conditions

Cardiomyopathy
SARS CoV-2 Infection
Congenital Heart Disease
Pulmonary Arterial Hypertension

Study type

Observational

Funder types

Other

Identifiers

NCT06784687
CARDIOPEDCOVID

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,376 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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