Quality of LifeHBSNCT02526082
Long-term Follow-up of the Helsinki Businessmen Study
An observational study of Quality of Life and Syndromes, run by Helsinki University Central Hospital.
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. Read more about this study
- Who is it for?
- Ages 31 to 46 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Syndromes, Aging
- What is being tested?
- Intervention
- How many people
- 3,490 participants
- Where
- No sites listed yet
- Study dates
- Jan 1964to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 46 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973
Who cannot join
- Non-participants
About this study
Official title: Long-term Follow-up of the Helsinki Businessmen Study Cohort of Men Born in 1919-1934
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.
Read the 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..
- Conditions
- Quality of Life, Syndromes, Aging, Cardiovascular Disease, Death
- Being tested
- Intervention
- Keywords
- cardiovascular disease, frailty, quality of life, mortality, prevention
- Medical subject headings
- Syndrome, Cardiovascular Diseases, Death, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Multifactorial intervention with lifestyle changes and drugs as needed
| Study group | Role | What they receive |
|---|---|---|
| Total, observational | Various cardiovascular risk groups described below | |
| High-risk intervention | Healthy but at high risk in 1974 Receives: Other: Intervention | |
| High-risk control | Healthy but at high risk in 1974 | |
| Low-risk conrtol | Healthy and at low risk in 1974 | |
| Sick control | Medications or clinical disease in 1974 | |
| Refused | Refused or no response in 1974 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total mortality: national registers
Measured: change from baseline up to 612 months
Secondary outcomes (5)
Health-related quality of life: questionnaire data
Measured: change from baseline up to 612 months
Geriatric syndromes and disability: questionnaires, clinical examinations, registers
Measured: change from baseline up to 612 months
Morbidity: self-report, national registers, hospital and autopsy records
Measured: change from baseline up to 612 months
Medications: self-report, national registers
Measured: change from baseline up to 612 months
Cause-specific mortality: national registers, autopsy records
Measured: change from baseline up to 612 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startJan 1964
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timo Strandberg, Helsinki University Central Hospital
- Investigators
- Timo E Strandberg, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526082
- Sponsor's protocol ID
- HBS Group
- Acronym
- HBS
- Status last verified
- Aug 2015
- First submitted
- 10 Jun 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 1870247Miettinen 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.
PubMed 4046137Strandberg 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.
PubMed 25014505Strandberg TE, Pitkala KH, Kivimaki M. Sleep duration in midlife and old age and risk of mortality over a 48-year follow-up: The Helsinki businessmen study (HBS) cohort. Maturitas. 2024 Jun;184:107964. doi: 10.1016/j.maturitas.2024.107964. Epub 2024 Mar 8.
PubMed 38471293Jyvakorpi 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.
PubMed 32844221Jyvakorpi 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.
PubMed 32444996
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of the Helsinki Businessmen Study Cohort of Men Born in 1919-1934
- ClinicalTrials.gov ID
- NCT02526082
- Acronym / sponsor ID
- HBS / HBS Group
- Conditions
- Quality of Life, Syndromes, Aging, Cardiovascular Disease, Death
- Keywords
- cardiovascular disease, frailty, quality of life, mortality, prevention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,490 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 1964
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Total, observational | – | –Various cardiovascular risk groups described below |
| High-risk intervention | – | Other: InterventionHealthy but at high risk in 1974 |
| High-risk control | – | –Healthy but at high risk in 1974 |
| Low-risk conrtol | – | –Healthy and at low risk in 1974 |
| Sick control | – | –Medications or clinical disease in 1974 |
| Refused | – | –Refused or no response in 1974 |
Who may qualify
- Ages
- 31 to 46 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973
Key exclusion criteria (1 listed)
- Non-participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionMultifactorial intervention with lifestyle changes and drugs as needed | Other | High-risk intervention |
Primary outcome
Total mortality: national registers
Time frame: change from baseline up to 612 months
5 secondary outcomes
Health-related quality of life: questionnaire data
Time frame: change from baseline up to 612 months
Geriatric syndromes and disability: questionnaires, clinical examinations, registers
Time frame: change from baseline up to 612 months
Morbidity: self-report, national registers, hospital and autopsy records
Time frame: change from baseline up to 612 months
Medications: self-report, national registers
Time frame: change from baseline up to 612 months
Cause-specific mortality: national registers, autopsy records
Time frame: change from baseline up to 612 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- Results publication: PubMed 1870247Strandberg 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.
- Results publication: PubMed 4046137Miettinen 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.
- Results publication: PubMed 25014505Strandberg 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.
- Derived from this study: PubMed 38471293Strandberg TE, Pitkala KH, Kivimaki M. Sleep duration in midlife and old age and risk of mortality over a 48-year follow-up: The Helsinki businessmen study (HBS) cohort. Maturitas. 2024 Jun;184:107964. doi: 10.1016/j.maturitas.2024.107964. Epub 2024 Mar 8.
- Derived from this study: PubMed 32844221Jyvakorpi 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.
- Derived from this study: PubMed 32444996Jyvakorpi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo E Strandberg, MD principal investigator
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Syndromes, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total mortality: national registers (time frame: change from baseline up to 612 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526082, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015; AzTrials last refreshed its copy on 7 Nov 2026.