- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02526082
Long-term Follow-up of the Helsinki Businessmen Study (HBS)
14. august 2015 oppdatert av: Timo Strandberg, Helsinki University Central Hospital
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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Detaljert beskrivelse
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..
Studietype
Observasjonsmessig
Registrering (Faktiske)
3490
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
31 år til 46 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
Inclusion Criteria:
- Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973
Exclusion Criteria:
- Non-participants
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Total, observational
Various cardiovascular risk groups described below
|
|
|
High-risk intervention
Healthy but at high risk in 1974
|
Multifactorial intervention with lifestyle changes and drugs as needed
|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Total mortality: national registers
Tidsramme: change from baseline up to 612 months
|
change from baseline up to 612 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Health-related quality of life: questionnaire data
Tidsramme: change from baseline up to 612 months
|
change from baseline up to 612 months
|
|
Geriatric syndromes and disability: questionnaires, clinical examinations, registers
Tidsramme: change from baseline up to 612 months
|
change from baseline up to 612 months
|
|
Morbidity: self-report, national registers, hospital and autopsy records
Tidsramme: change from baseline up to 612 months
|
change from baseline up to 612 months
|
|
Medications: self-report, national registers
Tidsramme: change from baseline up to 612 months
|
change from baseline up to 612 months
|
|
Cause-specific mortality: national registers, autopsy records
Tidsramme: change from baseline up to 612 months
|
change from baseline up to 612 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Timo E Strandberg, MD, Helsinki University Central Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 1964
Primær fullføring (Forventet)
1. desember 2040
Studiet fullført (Forventet)
1. desember 2040
Datoer for studieregistrering
Først innsendt
10. juni 2015
Først innsendt som oppfylte QC-kriteriene
14. august 2015
Først lagt ut (Anslag)
18. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. august 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. august 2015
Sist bekreftet
1. august 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HBS Group
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