Long-term Follow-up of the Helsinki Businessmen Study

Quality of Life Clinical Trial

— HBS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02526082
• Other study ID #: HBS Group
• Status: Active, not recruiting
• Phase: N/A
• First received: June 10, 2015
• Last updated: August 14, 2015
• Start date: January 1964
• Est. completion date: December 2040

Study information

• Verified date: August 2015
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3490
• Est. completion date: December 2040
• Est. primary completion date: December 2040
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 31 Years to 46 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-participants

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aging
• Cardiovascular Disease
• Cardiovascular Diseases
• Death
• Quality of Life
• Syndromes

Intervention

Other:
• Intervention
Multifactorial intervention with lifestyle changes and drugs as needed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

References & Publications (3)

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. — View Citation

Strandberg AY, Strandberg TE, Stenholm S, Salomaa VV, Pitkälä 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: 10.10 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total mortality: national registers		change from baseline up to 612 months	No
Secondary	Health-related quality of life: questionnaire data		change from baseline up to 612 months	No
Secondary	Geriatric syndromes and disability: questionnaires, clinical examinations, registers		change from baseline up to 612 months	No
Secondary	Morbidity: self-report, national registers, hospital and autopsy records		change from baseline up to 612 months	No
Secondary	Medications: self-report, national registers		change from baseline up to 612 months	No
Secondary	Cause-specific mortality: national registers, autopsy records		change from baseline up to 612 months	No