Long-term Follow-up of the Helsinki Businessmen Study

Active, not recruiting

• Conditions: Syndromes; Aging; Cardiovascular Disease; Death; Quality of Life
• Interventions: Other: Intervention

• Registration Number: NCT02526082
• Lead Sponsor: Helsinki University Central Hospital

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 Timeline

• Study Start: 1964-01
• Study First Submitted: 2015-06-10
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-14
• Last Update Submitted: 2015-08-14
• Study First Posted: 2015-08-18
• Last Update Posted: 2015-08-18
• Primary Completion: 2040-12
• Study Completion: 2040-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 3490

Inclusion Criteria

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

Exclusion Criteria

• Non-participants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-risk intervention	Intervention	Healthy but at high risk in 1974

Primary Outcome Measures

Name	Time	Method
Total mortality: national registers	change from baseline up to 612 months

Secondary Outcome Measures

Name	Time	Method
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