NCT04442685

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

4.5 years

First QC Date

March 29, 2019

Last Update Submit

January 30, 2024

Conditions

Keywords

congenital heart diseasepediatricregistryheart disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Datacollection during 10 years, whereas an average incident is detected during one year

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population from newborns to adolescents with newly diagnosed heart disease is recorded.

You may qualify if:

  • Patients with heart diseases and
  • age at diagnosis between 0 and 18 years and
  • resident and / or treated in Switzerland and
  • signed informed consent

You may not qualify if:

  • No written consent. The number of people who refuse to participate will be recorded per center for drop out analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Childrens Hospital Zurich

Zurich, 8032, Switzerland

Location

Related Links

MeSH Terms

Conditions

Heart Defects, CongenitalHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Christian Balmer

    PI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Dr. Christian Balmer

Study Record Dates

First Submitted

March 29, 2019

First Posted

June 22, 2020

Study Start

June 1, 2019

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
The first Data will be available 2020.
Access Criteria
all IPD that underlie results in a publication
More information

Locations