NCT02007031

Brief Summary

Wintertime is associated with increased morbidity and mortality and a majority is related to cardiovascular causes, such as myocardial infarctions, heart failures, and strokes. It is also known, that both acute and long-term cold exposure increase blood pressure and cardiac workload, and this may contribute to the observed excess morbidity and mortality during the cold season. Although the effects of cold on blood pressure are known among healthy people, these responses among risk groups, such as hypertensive people, are not established. In addition, changes in cardiac electrical activity or autonomic regulation are largely unknown. The cardiovascular responses in the cold could be different among hypertensive people because of disturbances in the circulatory regulation or function, such as aortic stiffening and increased vasomotor tone of peripheral arteries due to endothelial dysfunction associated with the disease. To assess this, a controlled experiment employing a cold exposure similar to everyday winter circumstances in a subarctic climate was performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

December 5, 2013

Last Update Submit

December 10, 2013

Conditions

Hypertension

Keywords

HypertensionCold temperatureBlood pressureElectrocardiography

Outcome Measures

Primary Outcomes (1)

  • Blood pressure response of hypertensive and normotensive subjects to cold exposure

    The study assesses the blood pressure response of hypertensive and normotensive subjects to facial cooling. Blood pressure is measured before (warm, +18°C), during (cold, 15°C) and after (warm, +18°C) the employed cold exposure. The duration of each of these exposures are 30, 15 and 30 min.

    2 hours (measured within the controlled experiment)

Secondary Outcomes (1)

  • Cardiac autonomic regulation

    2 hours (measured within each controlled experiment), ECG recorded continuously

Study Arms (2)

Hypertensive subjects

Hypertensive subjects are exposed to brief cold exposure (-15 C for 15 min) mainly subjected to their facial region during which their cardiovascular responses are registered.

Normotensive subjects

Normotensive subjects are exposed to brief cold exposure (-15 C for 15 min) mainly subjected to their facial region during which their cardiovascular responses are registered.

Eligibility Criteria

Age55 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study participants were included according to a population based recruitment where a random sample of 1000 men (55-65 years old) living in Oulu, Finland was drawn from the Finnish Population Register. They were screened by telephone interviews for eligibility for the study. Eligible attendees measured their blood pressure home for a week according to the recommendations of the European Society of Hypertension and were classified either to hypertensive (systolic blood pressure ≥135 and/or diastolic blood pressure ≥85 mmHg) or normotensive (blood pressure \<135/85mmHg). For the study we aimed at a 2:1 ratio of hypertensive and normotensive. The final study group consisted of 56 hypertensive and 35 normotensive middle-aged men.

You may qualify if:

  • Measured BP (home measurements of one week) above 135/85 mmHg were selected to the group of hypertensive subjects.
  • Those with BP below 135/85 mmHg were selected as controls.

You may not qualify if:

  • Presence of coronary heart disease, respiratory diseases, and the use of antihypertensive drug treatment.
  • an average home BP ≥175/105 mmHg, initiating antihypertensive drug treatment, failed home BP measurements, and having a respiratory infection within a week prior to the controlled measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oulu

Oulu, FI90014, Finland

Location

Finnish Institute of Occupational Health

Oulu, FI90220, Finland

Location

Related Publications (13)

  • Ikaheimo TM, Lehtinen T, Antikainen R, Jokelainen J, Nayha S, Hassi J, Keinanen-Kiukaanniemi S, Laatikainen T, Jousilahti P, Jaakkola JJ. Cold-related cardiorespiratory symptoms among subjects with and without hypertension: the National FINRISK Study 2002. Eur J Public Health. 2014 Apr;24(2):237-43. doi: 10.1093/eurpub/ckt078. Epub 2013 Jun 22.

    PMID: 23794677BACKGROUND

  • Edwards DG, Gauthier AL, Hayman MA, Lang JT, Kenefick RW. Acute effects of cold exposure on central aortic wave reflection. J Appl Physiol (1985). 2006 Apr;100(4):1210-4. doi: 10.1152/japplphysiol.01154.2005. Epub 2005 Oct 13.

    PMID: 16223975BACKGROUND

  • Modesti PA, Morabito M, Massetti L, Rapi S, Orlandini S, Mancia G, Gensini GF, Parati G. Seasonal blood pressure changes: an independent relationship with temperature and daylight hours. Hypertension. 2013 Apr;61(4):908-14. doi: 10.1161/HYPERTENSIONAHA.111.00315. Epub 2013 Feb 4.

    PMID: 23381792BACKGROUND

  • Barnett AG, Sans S, Salomaa V, Kuulasmaa K, Dobson AJ; WHO MONICA Project. The effect of temperature on systolic blood pressure. Blood Press Monit. 2007 Jun;12(3):195-203. doi: 10.1097/MBP.0b013e3280b083f4.

    PMID: 17496471BACKGROUND

  • Barnett AG, Dobson AJ, McElduff P, Salomaa V, Kuulasmaa K, Sans S; WHO MONICA Project. Cold periods and coronary events: an analysis of populations worldwide. J Epidemiol Community Health. 2005 Jul;59(7):551-7. doi: 10.1136/jech.2004.028514.

    PMID: 15965137BACKGROUND

  • Parati G, Stergiou GS, Asmar R, Bilo G, de Leeuw P, Imai Y, Kario K, Lurbe E, Manolis A, Mengden T, O'Brien E, Ohkubo T, Padfield P, Palatini P, Pickering TG, Redon J, Revera M, Ruilope LM, Shennan A, Staessen JA, Tisler A, Waeber B, Zanchetti A, Mancia G; ESH Working Group on Blood Pressure Monitoring. European Society of Hypertension practice guidelines for home blood pressure monitoring. J Hum Hypertens. 2010 Dec;24(12):779-85. doi: 10.1038/jhh.2010.54. Epub 2010 Jun 3.

    PMID: 20520631BACKGROUND

  • Komulainen S, Rintamaki H, Virokannas H, Keinanen-Kiukaanniemi S. Blood pressure responses to whole-body cold exposure: effect of metoprolol. J Hum Hypertens. 2004 Dec;18(12):905-6. doi: 10.1038/sj.jhh.1001758. No abstract available.

    PMID: 15269706BACKGROUND

  • Bhaskaran K, Hajat S, Haines A, Herrett E, Wilkinson P, Smeeth L. Short term effects of temperature on risk of myocardial infarction in England and Wales: time series regression analysis of the Myocardial Ischaemia National Audit Project (MINAP) registry. BMJ. 2010 Aug 10;341:c3823. doi: 10.1136/bmj.c3823.

    PMID: 20699305BACKGROUND

  • Sun Z. Cardiovascular responses to cold exposure. Front Biosci (Elite Ed). 2010 Jan 1;2(2):495-503. doi: 10.2741/e108.

    PMID: 20036896BACKGROUND

  • Nayha S. Environmental temperature and mortality. Int J Circumpolar Health. 2005 Dec;64(5):451-8. doi: 10.3402/ijch.v64i5.18026.

    PMID: 16440607BACKGROUND

  • Hintsala H, Kandelberg A, Herzig KH, Rintamaki H, Mantysaari M, Rantala A, Antikainen R, Keinanen-Kiukaanniemi S, Jaakkola JJ, Ikaheimo TM. Central aortic blood pressure of hypertensive men during short-term cold exposure. Am J Hypertens. 2014 May;27(5):656-64. doi: 10.1093/ajh/hpt136. Epub 2013 Aug 20.

    PMID: 23964061RESULT

  • Hintsala HE, Kiviniemi AM, Antikainen R, Mantysaari M, Jokelainen J, Hassi J, Tulppo MP, Herzig KH, Keinanen-Kiukaanniemi S, Rintamaki H, Jaakkola JJK, Ikaheimo TM. High Home Blood Pressure Variability Associates With Exaggerated Blood Pressure Response to Cold Stress. Am J Hypertens. 2019 May 9;32(6):538-546. doi: 10.1093/ajh/hpz011.

    PMID: 30984970DERIVED

  • Hintsala H, Kentta TV, Tulppo M, Kiviniemi A, Huikuri HV, Mantysaari M, Keinanen-Kiukaannemi S, Bloigu R, Herzig KH, Antikainen R, Rintamaki H, Jaakkola JJ, Ikaheimo TM. Cardiac repolarization and autonomic regulation during short-term cold exposure in hypertensive men: an experimental study. PLoS One. 2014 Jul 1;9(7):e99973. doi: 10.1371/journal.pone.0099973. eCollection 2014.

    PMID: 24983379DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Tiina M Ikäheimo, Ph.D.

    University of Oulu

    PRINCIPAL INVESTIGATOR

  • Jouni JK Jaakkola, MD, Ph.D.

    University of Oulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral researcher

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

January 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

FI(2)