Skip to main content
  • Research Article
  • Open access
  • Published:

Treatment of White Coat HYpertension in the Very Elderly Trial (HYVET 2) - Feasibility of a Randomized Controlled Trial (Study Protocol)

Abstract

The results of HYpertension in the Very Elderly Trial (HYVET) were crucial in providing evidence of benefit of the treatment of hypertension in those 80 years or older. Following a subsequent sub study analysis of the HYVET data there is a suggestion that 50% of patients in the main study had White Coat Hypertension (WCH), defined as clinic BP readings >140/90 mmHg and ambulatory BP readings <135/85 mmHg. Currently, definitive evidence in support of treatment for such individuals is not available. HYVET 2 has been designed in order to assess the feasibility of conducting a randomized controlled trial which might determine whether the treatment of WCH in the very elderly is clinically beneficial. One hundred participants aged ≥75 years diagnosed with WCH will be recruited from General Practices (GPs) in UK. Randomization will be 1:1 to a treatment arm (indapamide and perindopril) and control arm (no treatment) and follow up will be for 52 weeks. HYVET 2 will report on feasibility outcomes including participant recruitment, adherence and withdrawal rates, willingness of GPs to recruit and randomize patients and the frequency of a composite of cardiovascular events. Simple descriptive statistics will be presented.

References

  1. World Health Organization (WHO). A global brief on hypertension; 2013. Available from: https://www.who.int/cardiovascular_diseases/publications/global_brief_hypertension/en/ (accessed October 2019).

  2. Health Survey for England; 2015. Available from: https://digital.nhs.uk/data-and-information/publications/statistical/health-survey-for-england/health-survey-for-england-2015-trend-tables (accessed October 2019).

  3. ONS 2016. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationprojections/compendium/subnationalpopulationprojectionssupplementaryanalysis/2014basedprojections/howthepopulationofenglandisprojectedtoage (accessed November 2019).

  4. Rastas S, Pirttilä T, Viramo P, Verkkoniemi A, Halonen P, Juva K, et al. Association between blood pressure and survival over 9 years in a general population aged 85 and older. J Am Geriatr Soc 2006;54:912–18.

    Google Scholar 

  5. Hakala SM, Tilvis RS, Strandberg TE. Blood pressure and mortality in an older population: a 5-year follow-up of the Helsinki Ageing Study. Eur Heart J 1997;18:1019–23.

    Google Scholar 

  6. Satish S, Freeman DH, Ray L, Goodwin JS. The relationship between blood pressure and mortality in the oldest old. J Am Geriatr Soc 2001;49:367–74.

    Google Scholar 

  7. Beckett NS, Peters R, Fletcher AE, Staessen JA, Liu L, Dumitrascu D, et al. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008;358:1887–98.

    Google Scholar 

  8. Fagard RH, Staessen JA, Thijs L, Gasowski J, Bulpitt CJ, Clement D, et al. Response to antihypertensive therapy in older patients with sustained and nonsustained systolic hypertension. Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Circulation 2000;102:1139–44.

    Google Scholar 

  9. Williamson JD, Supiano MA, Applegate WB, Berlowitz DR, Campbell RC, Chertow GM, et al. Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ≥75 years: a randomized clinical trial. JAMA 2016;315:2673–82.

    Google Scholar 

  10. NICE hypertension guideline. 2019. Available from: https://www.nice.org.uk/guidance/ng136/evidence/full-guideline-august-2011-6898565197?tab=evidence (accessed November 2019).

  11. Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J 2018;39:3021–104.

    Google Scholar 

  12. Whelton PK, Carey RM, Aronow WS, Casey DE, Collins KJ, Dennison Himmelfarb C, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/ American Heart Association Task Force on clinical practice guidelines. Hypertension 2018;71:1269–324.

    Google Scholar 

  13. Mancia G, Bombelli M, Facchetti R, Madotto F, Quarti-Trevano F, Polo Friz H, et al. Long-term risk of sustained hypertension in white-coat or masked hypertension. Hypertension 2009;54:226–32.

    Google Scholar 

  14. Gorostidi M, Vinyoles E, Banegas JR, de la Sierra A. Prevalence of white-coat and masked hypertension in national and international registries. Hypertension Res 2015;38:1–7.

    Google Scholar 

  15. Pierdomenico SD, Cuccurullo F. Prognostic value of white-coat and masked hypertension diagnosed by ambulatory monitoring in initially untreated subjects: an updated meta analysis. Am J Hypertens 2011;24:52–8.

    Google Scholar 

  16. Franklin SS, Thijs L, Hansen TW, Li Y, Boggia J, Kikuya M, et al. Significance of white-coat hypertension in older persons with isolated systolic hypertension: a meta-analysis using the International Database on Ambulatory Blood Pressure Monitoring in Relation to Cardiovascular Outcomes population. Hypertension 2012;59:564–71.

    Google Scholar 

  17. Bulpitt CJ, Beckett N, Peters R, Staessen JA, Wang JG, Comsa M, et al. Does white coat hypertension require treatment over age 80?: results of the hypertension in the very elderly trial ambulatory blood pressure side project. Hypertension 2013;61:89–94.

    Google Scholar 

  18. Indapamide SPC. 2019. Available from: https://www.medicines.org.uk/emc/medicine/1946 (accessed October 2019).

  19. Perindopril SPC. 2019. Available from: https://www.medicines.org.uk/emc/product/4389 (accessed November 2019).

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Michael Okorie.

Additional information

Peer review under responsibility of the Association for Research into Arterial Structure and Physiology

Data availability statement: The data that support any aspects of this study protocol are available from the corresponding author, (MO), upon reasonable request.

Rights and permissions

This is an open access article distributed under the CC BY-NC 4.0 license (http://creativecommons.org/licenses/by-nc/4.0/).

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Okorie, M., Ali, K., Bremner, S. et al. Treatment of White Coat HYpertension in the Very Elderly Trial (HYVET 2) - Feasibility of a Randomized Controlled Trial (Study Protocol). Artery Res 25, 19–25 (2019). https://doi.org/10.2991/artres.k.191106.001

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2991/artres.k.191106.001

Keywords