Swiss Longitudinal Cohort

Cardiovascular Risk Factors Clinical Trial

Official title:

Swiss Longitudinal Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02282748
• Other study ID #: SNCTP 000000612
• Status: Recruiting
• Start date: October 2014
• Est. completion date: September 2034

Study information

• Verified date: February 2020
• Source: Hypertension Excellence Centre Lucerne
• Contact: Paul Erne, MD
• Email: paul.erne[@]erne-net.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The planned research project is a prospective population-based cohort study, similar to the well-known Framingham study in the United States. So far, there is no similar research project in Switzerland.

It is planned to examine of three Swiss municipalities. Recruitment in a first Swiss municipality (Lostallo/Cama GR) started 2014 and ended in 2019. Overall, 496 participants were recruited in this municipality. The five-year follow-up in this municipality started in 2019. It is planned to start recruitment in a second Swiss municipality (Uznach SG) in 2020.

The examinations embrace a broad spectrum of measurements (for details the investigators refer to the published study protocol).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2034
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Resident of Cama GR, Lostallo GR, or Uznach SG

• Age =6 years (no upper age limit), for voluntary blood sample =18 years

• Willing to participate in long-term study

• Written informed consent (in participants =6 years and <18 years signed by parents)

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Cardiovascular Risk Factors

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Switzerland	Cama	Cama	Graubünden
Switzerland	Lostallo	Lostallo	Graubünden
Switzerland	Linth Hospital	Uznach	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Hypertension Excellence Centre Lucerne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in cardiovascular risk factors	Cardiovascular risk factors will be assessed using validated measurements.	10 years
Primary	Mortality		10 years
Secondary	Cardiovascular events	Cardiovascular events (i.e. stroke, myocardial infarction) will be assessed using questionnaires and case records.	10 years
Secondary	Heart function	Heart function will be assessed using questionnaires for symptoms, clinical examination and measurement of electromechanical activation time.	10 years
Secondary	Cognitive function	Cognitive function will be assessed using validated instruments.	10 years
Secondary	Kidney function	Kidney function will be assessed using laboratory measurements.	10 years
Secondary	Autonomy	Autonomy wil be assessed using validated instruments.	10 years
Secondary	Nursing home admission	Nursing home admissions will be assessed using standardized questions.	10 years