Congenital Heart DiseaseNCT06784687
Evaluation of the Prevalence and Clinical Manifestation of SARS-CoV-2 Infection in a Population of Adult and Pediatric Patients With Congenital Heart Disease
An observational study of Congenital Heart Disease and Cardiomyopathy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Cardiomyopathy, Pulmonary Arterial Hypertension
- How many people
- 2,376 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with congenital heart disease undergoing corrective or palliative surgical treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Congenital Heart Disease, Cardiomyopathy, Pulmonary Arterial Hypertension, SARS CoV-2 Infection
- Medical subject headings
- Heart Defects, Congenital, Cardiomyopathies, Pulmonary Arterial Hypertension, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upon completion of the questionnaire by patient on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Aug 2021
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,376 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Bonetti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784687
- Sponsor's protocol ID
- CARDIOPEDCOVID
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06784687
- Acronym / sponsor ID
- CARDIOPEDCOVID
- Conditions
- Congenital Heart Disease, Cardiomyopathy, Pulmonary Arterial Hypertension, SARS CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,376 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with congenital heart disease undergoing corrective or palliative surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of SARS-CoV-2 infection evaluation
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Bonetti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Cardiomyopathy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of SARS-CoV-2 infection evaluation (time frame: Upon completion of the questionnaire by patient on day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.