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

NCT06784687 | Completed

• 1 other identifier: CARDIOPEDCOVID
• Study Type: observational
• Target: 2,376
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Severity of SARS-CoV-2 infection evaluation

  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.

  Upon completion of the questionnaire by patient on day 1

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Cardiomyopathies; Pulmonary Arterial Hypertension; COVID-19

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Simone Bonetti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 20, 2025
• Study Start: August 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: January 20, 2025

Record last verified: 2024-11

Locations

IT (1)