<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04442685</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC 2018-01229</org_study_id>
    <nct_id>NCT04442685</nct_id>
  </id_info>
  <brief_title>Swiss Pediatric Heart Cohort</brief_title>
  <acronym>SPHC</acronym>
  <official_title>The Swiss Registry for Heart Diseases in Children A Datacollection for Congenital and Acquired Heart Diseases in Children Living in Switzerland.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Children's Hospital, Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ostschweizer Kinderspital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Children's Hospital, Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Swiss Pediatric Heart Cohort aims to collect representative longitudinal data on all&#xD;
      children diagnosed with a clinically relevant heart disease in Switzerland. The long-term&#xD;
      goal is to optimize diagnosis and therapy, and to allow setting up national research&#xD;
      projects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the entire spectrum of childhood diseases, heart disease occupy a special position&#xD;
      regarding incidence; Congenital heart defects are among the most common organ abnormalities,&#xD;
      moderate and severe forms of congenital heart diseases occur with a frequency of about 6 to 8&#xD;
      per 1000 live births. Rapid advances in diagnostic and therapeutic options in recent decades&#xD;
      have led to a spectacular improvement in prognosis.&#xD;
&#xD;
      So far, data from heart diseases in children in Switzerland are not recorded centrally. A&#xD;
      national registry collecting all relevant personal and medical data, as in other European&#xD;
      countries, e.g. Finland, Sweden or Germany does not exist. The incidence and course of heart&#xD;
      diseases in children in Switzerland are therefore unknown and can only be extrapolated&#xD;
      indirectly from other countries. The SPHC project was therefore initiated by the Swiss&#xD;
      pediatric cardiologists and is supported by its professional association, the Swiss Society&#xD;
      for Pediatric Cardiology (Schweizerische Gesellschaft für pädiatrische Kardiologie; SGPK), as&#xD;
      well as by its research association, the Association for Pediatric Heart Research Switzerland&#xD;
      (Verein Kinderherzforschung Schweiz; VKHFS).&#xD;
&#xD;
      The aim of medical efforts in children with heart disease has shifted in recent years from a&#xD;
      mere assurance of survival to an overall optimization of morbidity. These patients are&#xD;
      expected to have a good perspective with normal growth, development, and quality of life well&#xD;
      into adulthood. This goal can be achieved by researching the incidence and disease&#xD;
      progression as well as the diagnostic and therapeutic measures in Switzerland. In this way,&#xD;
      conclusions can be drawn, which lead to a modification of the therapeutic procedures and&#xD;
      finally improve the prognosis of heart disease. The statistical significance of individual&#xD;
      case descriptions or retrospective case series of individual centers, as practiced today, is&#xD;
      insufficient for these purposes.&#xD;
&#xD;
      The aim of the SPHC is to optimize the diagnosis and therapy of all children with heart&#xD;
      disease in Switzerland. In particular, the following goals are pursued:&#xD;
&#xD;
        -  Describe incidence of heart diseases in childhood&#xD;
&#xD;
        -  Enable research on the cause of the disease&#xD;
&#xD;
        -  Record long-term history of mortality, morbidity and quality of life&#xD;
&#xD;
        -  Describe therapeutic measures (medications, cardiac catheterization, cardiac surgery)&#xD;
           regarding efficacy and safety&#xD;
&#xD;
        -  Identify risk factors for a good / bad prognosis&#xD;
&#xD;
        -  Promote prevention&#xD;
&#xD;
        -  Collect basic data for the planning of care and for health economic analyses in the&#xD;
           context of public health research projects&#xD;
&#xD;
        -  Provide data for international collaborative studies&#xD;
&#xD;
        -  A collaboration with Registry of adults with congenital heart defects (Grown Up&#xD;
           Congenital Heart Disease, GUCH) is anticipated. This registry also uses SecuTrial® and&#xD;
           is also located in the Clinical Trial Centre (CTC) of the University Zürich.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2029</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2029</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>18 Years</target_duration>
  <primary_outcome>
    <measure>SPHC, a prospective quantitative datacollection of heart diseases in Swiss children during ten years.</measure>
    <time_frame>Datacollection during 10 years, whereas an average incident is detected during one year</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <enrollment type="Anticipated">780</enrollment>
  <condition>Heart Disease Congenital</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The population from newborns to adolescents with newly diagnosed heart disease is recorded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with heart diseases and&#xD;
&#xD;
          -  age at diagnosis between 0 and 18 years and&#xD;
&#xD;
          -  resident and / or treated in Switzerland and&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No written consent. The number of people who refuse to participate will be recorded&#xD;
             per center for drop out analysis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Balmer</last_name>
    <role>Principal Investigator</role>
    <affiliation>PI</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chantal Costan</last_name>
    <phone>+41796173734</phone>
    <email>chantal.costan@kispi.uzh.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christan Balmer, PD</last_name>
    <phone>+41442667379</phone>
    <email>christian.balmer@kispi.uzh.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Childrens Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chantal Costan</last_name>
      <phone>+41796173734</phone>
      <email>chantal.costan@kispi.uzh.ch</email>
    </contact>
    <contact_backup>
      <last_name>Christian Balmer, PD</last_name>
      <phone>+41442667379</phone>
      <email>christian.balmer@kispi.uzh.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Reller+MD%2C+Strickland+MJ%2C+Riehle-Colarusso+T%2C+Mahle+WT%2C+Correa+A.+Prevalence+of+congenital+heart+defects+in+metropolitan+Atlanta%2C+1998-2005.+J+Pediatr.+2008+Dec%3B153(6)%3A807-13.</url>
    <description>Prevalence of congenital heart defects</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Hoffman+JI%2C+Kaplan+S.+The+incidence+of+congenital+heart+disease.+Journal+of+the+American+College+of+Cardiology.+2002+Jun+19%3B39(12)%3A1890-900</url>
    <description>Incidence of congenital heart defects</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 29, 2019</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Children's Hospital, Zurich</investigator_affiliation>
    <investigator_full_name>Christian Balmer</investigator_full_name>
    <investigator_title>Principal Investigator Dr. Christian Balmer</investigator_title>
  </responsible_party>
  <keyword>congenital heart disease</keyword>
  <keyword>pediatric</keyword>
  <keyword>registry</keyword>
  <keyword>heart disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.&#xD;
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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>The first Data will be available 2020.</ipd_time_frame>
    <ipd_access_criteria>all IPD that underlie results in a publication</ipd_access_criteria>
    <ipd_url>http://www.kinderherzforschung.ch</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04442685
org study id: BASEC 2018-01229
nct id: NCT04442685
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
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
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: No
last name: Christian Balmer
role: Principal Investigator
affiliation: PI
last name: Chantal Costan
phone: +41796173734
email: chantal.costan@kispi.uzh.ch
last name: Christan Balmer, PD
phone: +41442667379
email: christian.balmer@kispi.uzh.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Reller+MD%2C+Strickland+MJ%2C+Riehle-Colarusso+T%2C+Mahle+WT%2C+Correa+A.+Prevalence+of+congenital+heart+defects+in+metropolitan+Atlanta%2C+1998-2005.+J+Pediatr.+2008+Dec%3B153(6)%3A807-13.
description: Prevalence of congenital heart defects
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Hoffman+JI%2C+Kaplan+S.+The+incidence+of+congenital+heart+disease.+Journal+of+the+American+College+of+Cardiology.+2002+Jun+19%3B39(12)%3A1890-900
description: Incidence of congenital heart defects
responsible party type: Principal Investigator
investigator affiliation: University Children's Hospital, Zurich
investigator full name: Christian Balmer
investigator title: Principal Investigator Dr. Christian Balmer
mesh term: Heart Diseases
sharing ipd: Yes
ipd description: 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.
ipd info type: Study Protocol
ipd time frame: The first Data will be available 2020.
ipd access criteria: all IPD that underlie results in a publication
ipd url: http://www.kinderherzforschung.ch