Adult Congenital Heart DiseaseACHD-BONCT06769529
Observational Cohort Study of Adult Patients With Congenital Heart Disease
An observational study of Adult Congenital Heart Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The aim of this retrospective and prospective single-center observational study is to evaluate the correct management of adult patients with congenital heart diseas (ACHD), based on the experience of a reference center such as the Institute of Pediatric Cardiology at Policlinico Sant'Orsola Malpighi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Congenital Heart Disease
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 18 Apr 2024to 1 May 2025
- How long will I take part?
- 11 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study includes all patients with congenital heart disease and age older than 18 years, referred to our Pediatric Cardiology Center from 14 February 2014 to 01 May 2025 going to represent one for a cohort of about 2000 patients.
Who may be able to join
- Patients with congenital heart disease in natural history or previously undergoing palliative or corrective surgery in the time period after 14/02/2014
- Obtaining informed consent
Who cannot join
- Age < 18 years
- Inability to obtain longitudinal data after the first follow-up performed at our Center.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Gabriele Egidy Assenza, MD, +390512149072, gabriele.egidyassenza@aosp.bo.it
About this study
The aim of this retrospective and prospective single-center observational study is to evaluate the correct management of adult patients with congenital heart diseas (ACHD), based on the experience of a reference center such as the Institute of Pediatric Cardiology at Policlinico Sant'Orsola Malpighi. The patients participating in this study will not be subjected to any procedures beyond normal daily clinical practice; likewise, the clinical variables that will be collected for the study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves naturalistic observation of current clinical practice without the application of any kind of intervention.
Read the detailed description
To date, there are an estimated 1 million patients, a population that is expected to grow by about 5%.annually. Given the increase in the number of such patients and their complexity, there is an increasing need to train experienced cardiologists and cardiac surgeons.
Our study is part of this panorama with the aim of assessing the correct management, taking into account the important psychological and sociological impact of these diseases, based on the experience of a reference centre such as the Institute of Paediatric Cardiology of the Policlinico Sant'Orsola Malpighi. The primary objective of the study is to identify the clinical and epidemiological characteristics of adult patients with heart disease congenital heart disease (in natural history or previously undergoing corrective or palliative intervention) and to define the need for intervention at a distance, both in terms of interventional and surgical procedures. 1) to describe cardiovascular adverse events and mortality in the target population during follow-up and any non-cardiac comorbidities; 2) to provide data defining the level of utilisation of healthcare resources (diagnostic tests withhigh complexity/cost diagnostic tests, hospital admissions, hospital admissions in high intensity wardscare, percutaneous interventional procedures, surgical procedures); 3) to assess data on quality of life, reproductive health (for the sub-population of female sub-population).
- Conditions
- Adult Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's medical history and diagnosis
Anthropometric data (age, sex, weight, height, body surface area) Detailed cardiologic diagnosis classified according to anatomic complexity Presence of univentricular physiology The presence of a genetic syndrome, or reasonable suspicion of its presence Major comorbidities The surgical and interventional cardiology history The level of urgency of admission to the department and the hemodynamics room Pregnancies prior to the visit The physiologic status Sinus rhythm Therapy
Measured: Through study duration, an average of 10 years
Clinical events
History of syncope since first evaluation History of NYHA III/IV since first evaluation History of moderate-grade left ventricular dysfunction History of severe grade left ventricular dysfunction Cyanosis History of cerebrovascular events (stroke/transient ischemic attack) History of endocarditis History of ventricular arrhythmias that required medical intervention History of supraventricular arrhythmias that required medical intervention Pace-Maker Implantation Implantation of Defibrillator (ICD) Implantation of Defibrillator-Resynchronizer (ICD-CRT)
Measured: Through study duration, an average of 10 years
Patient visits, diagnostic tests, hospitalizations, and interventions
Longitudinal clinical evaluations Longitudinal advanced imaging assessments Longitudinal hospitalizations oIndications for hospitalization Longitudinal transcatheter procedures Type of transcatheter procedure Longitudinal surgical procedures Type of surgical procedure
Measured: Through study duration, an average of 10 years
Clinical events after cardiology evaluation
Death Ventricular arrhythmia with need for intervention Supraventricular arrhythmia with need for intervention Progression to NYHA functional class III/IV Unscheduled hospitalization Bleeding Development of pulmonary hypertension Cerebrovascular event (stroke/transient ischemic attack) Plastic bronchitis Protido-dispersing enteropathy Failure of Fontan circulation Evaluation for cardiac transplantation
- Refusal for cardiac transplantation
- Listing for cardiac transplantation
- Endocarditis
- Cardiac transplantation
Measured: Through study duration, an average of 10 years
The manner of death
Sudden cardiac death Heart death from heart failure Cardiac death related to surgical procedure Cardiac death related to transcatheter procedure Cardiac death from cerebrovascular event Cardiac death from endocarditis or sepsis Noncardiac neoplastic Noncardiac by renal failure Noncardiac by suicide Other noncardiac modality
Measured: Through study duration, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start18 Apr 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult 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
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 11 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriele Egidy Assenza, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769529
- Sponsor's protocol ID
- ACHD-BO
- Acronym
- ACHD-BO
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 31 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 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of Adult Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06769529
- Acronym / sponsor ID
- ACHD-BO / ACHD-BO
- Conditions
- Adult Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 10 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 aim of this retrospective and prospective single-center observational study is to evaluate the correct management of adult patients with congenital heart diseas (ACHD), based on the experience of a reference center such as the Institute of Pediatric Cardiology at Policlinico Sant'Orsola Malpighi. The patients participating in this study will not be subjected to any procedures beyond normal daily clinical practice; likewise, the clinical variables that will be collected for the study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves naturalistic observation of current clinical practice without the application of any kind of intervention.
Detailed description
To date, there are an estimated 1 million patients, a population that is expected to grow by about 5%.annually. Given the increase in the number of such patients and their complexity, there is an increasing need to train experienced cardiologists and cardiac surgeons.
Our study is part of this panorama with the aim of assessing the correct management, taking into account the important psychological and sociological impact of these diseases, based on the experience of a reference centre such as the Institute of Paediatric Cardiology of the Policlinico Sant'Orsola Malpighi. The primary objective of the study is to identify the clinical and epidemiological characteristics of adult patients with heart disease congenital heart disease (in natural history or previously undergoing corrective or palliative intervention) and to define the need for intervention at a distance, both in terms of interventional and surgical procedures. 1) to describe cardiovascular adverse events and mortality in the target population during follow-up and any non-cardiac comorbidities; 2) to provide data defining the level of utilisation of healthcare resources (diagnostic tests withhigh complexity/cost diagnostic tests, hospital admissions, hospital admissions in high intensity wardscare, percutaneous interventional procedures, surgical procedures); 3) to assess data on quality of life, reproductive health (for the sub-population of female sub-population).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 11 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study includes all patients with congenital heart disease and age older than 18 years, referred to our Pediatric Cardiology Center from 14 February 2014 to 01 May 2025 going to represent one for a cohort of about 2000 patients.
Key inclusion criteria (2 listed)
- Patients with congenital heart disease in natural history or previously undergoing palliative or corrective surgery in the time period after 14/02/2014
- Obtaining informed consent
Key exclusion criteria (2 listed)
- Age < 18 years
- Inability to obtain longitudinal data after the first follow-up performed at our Center.
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
Patient's medical history and diagnosis
Time frame: Through study duration, an average of 10 years
Anthropometric data (age, sex, weight, height, body surface area) Detailed cardiologic diagnosis classified according to anatomic complexity Presence of univentricular physiology The presence of a genetic syndrome, or reasonable suspicion of its presence Major comorbidities The surgical and interventional cardiology history The level of urgency of admission to the department and the hemodynamics room Pregnancies prior to the visit The physiologic status Sinus rhythm Therapy
Clinical events
Time frame: Through study duration, an average of 10 years
History of syncope since first evaluation History of NYHA III/IV since first evaluation History of moderate-grade left ventricular dysfunction History of severe grade left ventricular dysfunction Cyanosis History of cerebrovascular events (stroke/transient ischemic attack) History of endocarditis History of ventricular arrhythmias that required medical intervention History of supraventricular arrhythmias that required medical intervention Pace-Maker Implantation Implantation of Defibrillator (ICD) Implantation of Defibrillator-Resynchronizer (ICD-CRT)
Patient visits, diagnostic tests, hospitalizations, and interventions
Time frame: Through study duration, an average of 10 years
Longitudinal clinical evaluations Longitudinal advanced imaging assessments Longitudinal hospitalizations oIndications for hospitalization Longitudinal transcatheter procedures Type of transcatheter procedure Longitudinal surgical procedures Type of surgical procedure
Clinical events after cardiology evaluation
Time frame: Through study duration, an average of 10 years
Death Ventricular arrhythmia with need for intervention Supraventricular arrhythmia with need for intervention Progression to NYHA functional class III/IV Unscheduled hospitalization Bleeding Development of pulmonary hypertension Cerebrovascular event (stroke/transient ischemic attack) Plastic bronchitis Protido-dispersing enteropathy Failure of Fontan circulation Evaluation for cardiac transplantation * Refusal for cardiac transplantation * Listing for cardiac transplantation * Endocarditis * Cardiac transplantation
The manner of death
Time frame: Through study duration, an average of 10 years
Sudden cardiac death Heart death from heart failure Cardiac death related to surgical procedure Cardiac death related to transcatheter procedure Cardiac death from cerebrovascular event Cardiac death from endocarditis or sepsis Noncardiac neoplastic Noncardiac by renal failure Noncardiac by suicide Other noncardiac modality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
Gabriele Egidy Assenza, 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 Adult Congenital Heart Disease, 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 31 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Egidy Assenza, MD (+390512149072, gabriele.egidyassenza@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's medical history and diagnosis (time frame: Through study duration, an average of 10 years). The study lists 5 primary outcomes in all. 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 31 Jan 2025.