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Clinical Trials/NCT02526082
NCT02526082Active, not recruitingNot Applicable

Long-term Follow-up of the Helsinki Businessmen Study Cohort of Men Born in 1919-1934

Helsinki University Central Hospital0 sites3,490 target enrollmentStarted: August 18, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
3,490
Primary Endpoint
Total mortality: national registers

Study Overview

Brief Summary

The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up through national registers since the 1980, and since 2000 with regular questionnaire surveys. Latest in 2015. Also clinical and laboratory studies have been performed in random subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.

Detailed Description

The Helsinki Businessmen Study (HBS) was originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups between 1964-1973, but since the beginning of 1970s it has developed into a clinico-epidemiological longitudinal study. Primary focus was on the prevention of cardiovascular diseases (CVD), but since 2000 focus has been shifting to geriatrics, and with its long follow-up (up to 50 years) HBS can be seen as a "life-course" study. Traditional CVD risk factors are available from the 1960s and in 1974 participants (available n=3310) were divided in groups according to their clinical status and CVD risk. Two high-risk groups (n=1222) and low-risk group (n=593) participated in a 5-year multifactorial primary prevention study in 1974-1980 (in-trial and post-trial results have been published in 1985 and 1991). The whole original cohort has been followed-up from national registers since 1985 and with regular questionnaire surveys since 2000. Random subcohorts have been studied clinically with laboratory and genetic examinations in 2003 and 2011. The latest questionnaire survey was performed in winter 2015 by which two thirds of the original cohort had died. Follow-up of the cohort is ongoing and new research questions formulated..

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
31 Years to 46 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973

Exclusion Criteria

  • Non-participants

Outcomes

Primary Outcomes

Total mortality: national registers

Time Frame: change from baseline up to 612 months

Secondary Outcomes

  • Health-related quality of life: questionnaire data(change from baseline up to 612 months)
  • Geriatric syndromes and disability: questionnaires, clinical examinations, registers(change from baseline up to 612 months)
  • Morbidity: self-report, national registers, hospital and autopsy records(change from baseline up to 612 months)
  • Medications: self-report, national registers(change from baseline up to 612 months)
  • Cause-specific mortality: national registers, autopsy records(change from baseline up to 612 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Timo Strandberg

Professor

Helsinki University Central Hospital

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