Clinical trial NCT02526082: Long-term Follow-up of the Helsinki Businessmen Study
Official title: Long-term Follow-up of the Helsinki Businessmen Study Cohort of Men Born in 1919-1934
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Quality of Life
Syndromes
Aging
Cardiovascular Disease
Death
Keywords: cardiovascular disease
frailty
quality of life
mortality
prevention
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 3490
Sex: MALE
Minimum age (years): 31
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups during 1964-1973, but since the beginning of 1970s it has developed into a clinic-epidemiological longitudinal study.

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..

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Non-participants

Primary outcomes:
measure: Total mortality: national registers
timeFrame: change from baseline up to 612 months
Secondary outcomes:
measure: Health-related quality of life: questionnaire data
timeFrame: change from baseline up to 612 months
measure: Geriatric syndromes and disability: questionnaires, clinical examinations, registers
timeFrame: change from baseline up to 612 months
measure: Morbidity: self-report, national registers, hospital and autopsy records
timeFrame: change from baseline up to 612 months
measure: Medications: self-report, national registers
timeFrame: change from baseline up to 612 months
measure: Cause-specific mortality: national registers, autopsy records
timeFrame: change from baseline up to 612 months
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Timo E Strandberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strandberg TE, Salomaa VV, Naukkarinen VA, Vanhanen HT, Sarna SJ, Miettinen TA. Long-term mortality after 5-year multifactorial primary prevention of cardiovascular diseases in middle-aged men. JAMA. 1991 Sep 4;266(9):1225-9.
citation: Miettinen TA, Huttunen JK, Naukkarinen V, Strandberg T, Mattila S, Kumlin T, Sarna S. Multifactorial primary prevention of cardiovascular diseases in middle-aged men. Risk factor changes, incidence, and mortality. JAMA. 1985 Oct 18;254(15):2097-102.
citation: Strandberg AY, Strandberg TE, Stenholm S, Salomaa VV, Pitkala KH, Tilvis RS. Low midlife blood pressure, survival, comorbidity, and health-related quality of life in old age: the Helsinki Businessmen Study. J Hypertens. 2014 Sep;32(9):1797-804. doi: 10.1097/HJH.0000000000000265.
citation: Jyvakorpi SK, Urtamo A, Kivimaki M, Salomaa V, Strandberg TE. Association of midlife body composition with old-age health-related quality of life, mortality, and reaching 90 years of age: a 32-year follow-up of a male cohort. Am J Clin Nutr. 2020 Nov 11;112(5):1287-1294. doi: 10.1093/ajcn/nqaa230.
citation: Jyvakorpi SK, Urtamo A, Kivimaki M, Strandberg TE. Associations of protein source, distribution and healthy dietary pattern with appendicular lean mass in oldest-old men: the Helsinki Businessmen Study (HBS). Eur Geriatr Med. 2020 Aug;11(4):699-704. doi: 10.1007/s41999-020-00330-1. Epub 2020 May 22.