Evaluation of the Prevalence and Clinical Manifestation of SARS-CoV-2 Infection in a Population of Adult and Pediatric Patients With Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease; Cardiomyopathy; Pulmonary Arterial Hypertension; SARS CoV-2 Infection

• Registration Number: NCT06784687
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31
• Status Verified: 2024-11
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2376

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of SARS-CoV-2 infection evaluation	Upon completion of the questionnaire by patient on day 1	The presence of ongoing SARS-CoV-2 infection will be defined as detection of viral RNA to a molecular swab or the detection of specific antigen at an antigenic swab, while the presence of previous infection will be defined as the presence of seroconversion for SARS-CoV-2 at a quantitative serological test. Severity of SARS-CoV-2 infection will be defined at different forms: * Severe form: Admission to intensive care unit, need for invasive respiratory support, death; * Moderate form: Need for hospitalization or home oxygen therapy, or Worsening of oxygen dependence in patients on chronic home oxygen therapy.; * Mild form: Symptomatic patients who do not meet the criteria for moderate or severe disease.; * Asymptomatic form: Patients with infection positivity who do not have symptoms of disease.; The patients' medical history and clinical data, as reported in the questionnaire, will be evaluated to look for possible risk factors for the development of severe forms of COVID-19 disease.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy