Heart Disease CongenitalSPHCNCT04442685
The Swiss Registry for Heart Diseases in Children Living in Switzerland. SPHC
An observational study of Heart Disease Congenital, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The Swiss Pediatric Heart Cohort aims to collect representative longitudinal data on all children diagnosed with a clinically relevant heart disease in Switzerland. The long-term goal is to optimize diagnosis and therapy, and to allow setting up national research projects. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Heart Disease Congenital
- How many people
- 590 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2019to 15 Dec 2023
- How long will I take part?
- 18 Years
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The population from newborns to adolescents with newly diagnosed heart disease is recorded.
Who may be able to join
- Patients with heart diseases and
- age at diagnosis between 0 and 18 years and
- resident and / or treated in Switzerland and
- signed informed consent
Who cannot join
- No written consent. The number of people who refuse to participate will be recorded per center for drop out analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Swiss Registry for Heart Diseases in Children A Datacollection for Congenital and Acquired Heart Diseases in Children Living in Switzerland.
The Swiss Pediatric Heart Cohort aims to collect representative longitudinal data on all children diagnosed with a clinically relevant heart disease in Switzerland. The long-term goal is to optimize diagnosis and therapy, and to allow setting up national research projects.
Read the detailed description
In the entire spectrum of childhood diseases, heart disease occupy a special position regarding incidence; Congenital heart defects are among the most common organ abnormalities, moderate and severe forms of congenital heart diseases occur with a frequency of about 6 to 8 per 1000 live births. Rapid advances in diagnostic and therapeutic options in recent decades have led to a spectacular improvement in prognosis.
So far, data from heart diseases in children in Switzerland are not recorded centrally. A national registry collecting all relevant personal and medical data, as in other European countries, e.g. Finland, Sweden or Germany does not exist. The incidence and course of heart diseases in children in Switzerland are therefore unknown and can only be extrapolated indirectly from other countries. The SPHC project was therefore initiated by the Swiss pediatric cardiologists and is supported by its professional association, the Swiss Society for Pediatric Cardiology (Schweizerische Gesellschaft für pädiatrische Kardiologie; SGPK), as well as by its research association, the Association for Pediatric Heart Research Switzerland (Verein Kinderherzforschung Schweiz; VKHFS).
The aim of medical efforts in children with heart disease has shifted in recent years from a mere assurance of survival to an overall optimization of morbidity. These patients are expected to have a good perspective with normal growth, development, and quality of life well into adulthood. This goal can be achieved by researching the incidence and disease progression as well as the diagnostic and therapeutic measures in Switzerland. In this way, conclusions can be drawn, which lead to a modification of the therapeutic procedures and finally improve the prognosis of heart disease. The statistical significance of individual case descriptions or retrospective case series of individual centers, as practiced today, is insufficient for these purposes.
The aim of the SPHC is to optimize the diagnosis and therapy of all children with heart disease in Switzerland. In particular, the following goals are pursued:
- Describe incidence of heart diseases in childhood
- Enable research on the cause of the disease
- Record long-term history of mortality, morbidity and quality of life
- Describe therapeutic measures (medications, cardiac catheterization, cardiac surgery) regarding efficacy and safety
- Identify risk factors for a good / bad prognosis
- Promote prevention
- Collect basic data for the planning of care and for health economic analyses in the context of public health research projects
- Provide data for international collaborative studies
- A collaboration with Registry of adults with congenital heart defects (Grown Up Congenital Heart Disease, GUCH) is anticipated. This registry also uses SecuTrial® and is also located in the Clinical Trial Centre (CTC) of the University Zürich.
- Conditions
- Heart Disease Congenital
- Keywords
- congenital heart disease, pediatric, registry, heart disease
- Medical subject headings
- Heart Defects, Congenital, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
SPHC, a prospective quantitative datacollection of heart diseases in Swiss children during ten years.
This registry is a prospective data collection. It includes all patients who are newly diagnosed with a heart disease and who have consented to it. As the amount of data increases, the registry becomes more important and informative.
The primarily outcome is to evaluate the quantity of congenital and acquired heart diseases in children living in Switzerland per Year compared to other countries.
Measured: Datacollection during 10 years, whereas an average incident is detected during one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jun 2019
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Disease CongenitalStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 590 participants (actual)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Ostschweizer Kinderspital, Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Christian Balmer, University Children's Hospital, Zurich
- Investigators
- Christian Balmer, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442685
- Sponsor's protocol ID
- BASEC 2018-01229
- Acronym
- SPHC
- Status last verified
- Jan 2024
- First submitted
- 29 Mar 2019
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Specific research projects: At the request of researchers, the SPHC is used for focused research projects. For example, a questionnaire study to patients and their parents to assess quality of life and health, or a survey to attending physicians for detailed treatment modalities. The additional data gained in these projects will be fed back into the database. Networking: In the future there is a possibility that the data of the SPHC can be networked with further registries: e.g. Swiss Birth Registry (Swiss Federal Statistical Office), Swiss National Cohort, RADIZ: Registry for Rare Diseases, Swiss Ped Net and possible further registries. Also the cooperation with the registry for adults with congenital heart diseases (GUCH Registry) is essential and an inclusion of all SPHC patients reaching the age of 18 years in the GUCH registry is anticipated.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Swiss Registry for Heart Diseases in Children A Datacollection for Congenital and Acquired Heart Diseases in Children Living in Switzerland.
- ClinicalTrials.gov ID
- NCT04442685
- Acronym / sponsor ID
- SPHC / BASEC 2018-01229
- Conditions
- Heart Disease Congenital
- Keywords
- congenital heart disease, pediatric, registry, heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- Ostschweizer Kinderspital, Centre Hospitalier Universitaire Vaudois
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 22 Jun 2020 (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 Swiss Pediatric Heart Cohort aims to collect representative longitudinal data on all children diagnosed with a clinically relevant heart disease in Switzerland. The long-term goal is to optimize diagnosis and therapy, and to allow setting up national research projects.
Detailed description
In the entire spectrum of childhood diseases, heart disease occupy a special position regarding incidence; Congenital heart defects are among the most common organ abnormalities, moderate and severe forms of congenital heart diseases occur with a frequency of about 6 to 8 per 1000 live births. Rapid advances in diagnostic and therapeutic options in recent decades have led to a spectacular improvement in prognosis.
So far, data from heart diseases in children in Switzerland are not recorded centrally. A national registry collecting all relevant personal and medical data, as in other European countries, e.g. Finland, Sweden or Germany does not exist. The incidence and course of heart diseases in children in Switzerland are therefore unknown and can only be extrapolated indirectly from other countries. The SPHC project was therefore initiated by the Swiss pediatric cardiologists and is supported by its professional association, the Swiss Society for Pediatric Cardiology (Schweizerische Gesellschaft für pädiatrische Kardiologie; SGPK), as well as by its research association, the Association for Pediatric Heart Research Switzerland (Verein Kinderherzforschung Schweiz; VKHFS).
The aim of medical efforts in children with heart disease has shifted in recent years from a mere assurance of survival to an overall optimization of morbidity. These patients are expected to have a good perspective with normal growth, development, and quality of life well into adulthood. This goal can be achieved by researching the incidence and disease progression as well as the diagnostic and therapeutic measures in Switzerland. In this way, conclusions can be drawn, which lead to a modification of the therapeutic procedures and finally improve the prognosis of heart disease. The statistical significance of individual case descriptions or retrospective case series of individual centers, as practiced today, is insufficient for these purposes.
The aim of the SPHC is to optimize the diagnosis and therapy of all children with heart disease in Switzerland. In particular, the following goals are pursued:
- Describe incidence of heart diseases in childhood
- Enable research on the cause of the disease
- Record long-term history of mortality, morbidity and quality of life
- Describe therapeutic measures (medications, cardiac catheterization, cardiac surgery) regarding efficacy and safety
- Identify risk factors for a good / bad prognosis
- Promote prevention
- Collect basic data for the planning of care and for health economic analyses in the context of public health research projects
- Provide data for international collaborative studies
- A collaboration with Registry of adults with congenital heart defects (Grown Up Congenital Heart Disease, GUCH) is anticipated. This registry also uses SecuTrial® and is also located in the Clinical Trial Centre (CTC) of the University Zürich.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Years
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population from newborns to adolescents with newly diagnosed heart disease is recorded.
Key inclusion criteria (4 listed)
- Patients with heart diseases and
- age at diagnosis between 0 and 18 years and
- resident and / or treated in Switzerland and
- signed informed consent
Key exclusion criteria (1 listed)
- No written consent. The number of people who refuse to participate will be recorded per center for drop out analysis.
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
SPHC, a prospective quantitative datacollection of heart diseases in Swiss children during ten years.
Time frame: Datacollection during 10 years, whereas an average incident is detected during one year
This registry is a prospective data collection. It includes all patients who are newly diagnosed with a heart disease and who have consented to it. As the amount of data increases, the registry becomes more important and informative. The primarily outcome is to evaluate the quantity of congenital and acquired heart diseases in children living in Switzerland per Year compared to other countries.
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 1 Feb 2024.
- Prevalence of congenital heart defectsLink provided by the sponsor.
- Incidence of congenital heart defectsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Specific research projects: At the request of researchers, the SPHC is used for focused research projects. For example, a questionnaire study to patients and their parents to assess quality of life and health, or a survey to attending physicians for detailed treatment modalities. The additional data gained in these projects will be fed back into the database. Networking: In the future there is a possibility that the data of the SPHC can be networked with further registries: e.g. Swiss Birth Registry (Swiss Federal Statistical Office), Swiss National Cohort, RADIZ: Registry for Rare Diseases, Swiss Ped Net and possible further registries. Also the cooperation with the registry for adults with congenital heart diseases (GUCH Registry) is essential and an inclusion of all SPHC patients reaching the age of 18 years in the GUCH registry is anticipated.
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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.
Christian Balmer principal investigator
PI
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 Heart Disease Congenital, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 1 Feb 2024. 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 Switzerland. 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?
SPHC, a prospective quantitative datacollection of heart diseases in Swiss children during ten years. (time frame: Datacollection during 10 years, whereas an average incident is detected during one year). 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 1 Feb 2024.