Hypertension Clinical Trial
— ColdHTNOfficial title:
Cardiovascular Responses to Cold Exposure in Hypertension
Verified date | December 2013 |
Source | University of Oulu |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 55 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Finland | Finnish Institute of Occupational Health | Oulu | |
Finland | University of Oulu | Oulu |
Lead Sponsor | Collaborator |
---|---|
University of Oulu | Finnish Institute of Occupational Health, National Institute for Health and Welfare, Finland, Verve Research, Oulu, Finland |
Finland,
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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2005 Oct 13. — View Citation
Hintsala H, Kandelberg A, Herzig KH, Rintamäki H, Mäntysaari M, Rantala A, Antikainen R, Keinänen-Kiukaanniemi S, Jaakkola JJ, Ikäheimo TM. Central aortic blood pressure of hypertensive men during short-term cold exposure. Am J Hypertens. 2014 May;27(5):6 — View Citation
Ikäheimo TM, Lehtinen T, Antikainen R, Jokelainen J, Näyhä S, Hassi J, Keinänen-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. — View Citation
Komulainen S, Rintamäki H, Virokannas H, Keinänen-Kiukaanniemi S. Blood pressure responses to whole-body cold exposure: effect of metoprolol. J Hum Hypertens. 2004 Dec;18(12):905-6. — View Citation
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. — View Citation
Näyhä S. Environmental temperature and mortality. Int J Circumpolar Health. 2005 Dec;64(5):451-8. — View Citation
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. Review. — View Citation
Sun Z. Cardiovascular responses to cold exposure. Front Biosci (Elite Ed). 2010 Jan 1;2:495-503. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | Cardiac autonomic regulation | ECG is recorded continuously during the controlled experiment (15 min warm 18 C, 15 min cold exposure -15 C and 20 min 18 C) from where cardiac electrical function, as well as autonomic nervous system regulation is assessed. | 2 hours (measured within each controlled experiment), ECG recorded continuously | No |
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