Validity of 1BPM for Diagnosis of Hypertension

Hypertension Clinical Trial

Official title:

Validity of 1-hour Blood Pressure Monitoring Against the Usual Methods for Diagnosis of Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147573
• Other study ID #: PI16/00660
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2020
• Source: Consorci d'Atenció Primària de Salut de l'Eixample
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. The classical methods such as office blood pressure measurement (OBPM) and home blood pressure monitoring (HBPM) have significant limitations. A recent British guideline recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these devices are not available at all health centers and they can only be used by one patient per day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM), to diagnose the hypertension.

Participants with suspected hypertension will be recruited from a population of patients seen at three primary health centers in an urban area. According to the sample size estimation, a minimum sample size of 214 participants would be needed for the study. Four diagnostic tests will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be compared to all other monitoring methods using the correlation coefficients and Bland Altman plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and specificity of the methods will also be calculated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• To visit routinely in the health centres where the study is carried out

Exclusion Criteria:

• Severe physical or cognitive limitations

• Atrial fibrillation or other heart rhythm disorders that could interfere with readings

• Arm Circumference > 42cm

• Arm with arteriovenous fistula

• Mental disorders

• Intolerance to the method of measurement

• Hospitalization during the study period

Related Conditions & MeSH terms

• Hypertension

Intervention

Diagnostic Test:
• 1-hour blood pressure monitoring (1BPM)
This method consists of performing blood pressure measurements programmed at 5-min intervals over 1 hour. Two extra recordings taken at the start and end of this period are discarded. Blood pressure is measured in a quiet room at the same health centre.
• 24-hour ambulatory blood pressure monitoring (ABPM)
The device is programmed to record the participant's BP every 20 min and 30 min during the day and night, respectively. Participants are advised to carry on with their normal daily activities, avoiding any intense physical exertion, and to remain at rest when their BP is being measured.
• Office blood pressure measurement (OBPM)
Two readings were made one minute apart with a validated automatic sphygmomanometer in a sitting position after five minutes of rest. The average of two readings is calculated. The procedure is repeated during 3 office visits at least a week apart.
• Home blood pressure monitoring (HBPM)
For each blood pressure recording, at least two consecutive measurements should be taken, at least one minute apart. Blood pressure should be recorded twice daily, ideally in the morning and evening. Blood pressure recording should continue for at least four consecutive days, ideally seven. The average of the above readings should be calculated, ignoring the first day.

Locations

Country	Name	City	State
Spain	Primary Care Center Casanova	Barcelona	Catalonia
Spain	Primary Care Center Comte Borrell	Barcelona	Catalonia
Spain	Primary Care Center Les Corts	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Consorci d'Atenció Primària de Salut de l'Eixample	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (18)

Banegas JR, Graciani A, de la Cruz-Troca JJ, León-Muñoz LM, Guallar-Castillón P, Coca A, Ruilope LM, Rodríguez-Artalejo F. Achievement of cardiometabolic goals in aware hypertensive patients in Spain: a nationwide population-based study. Hypertension. 2012 Oct;60(4):898-905. doi: 10.1161/HYPERTENSIONAHA.112.193078. Epub 2012 Sep 4. — View Citation

Banegas JR, Segura J, Sobrino J, Rodríguez-Artalejo F, de la Sierra A, de la Cruz JJ, Gorostidi M, Sarría A, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Effectiveness of blood pressure control outside the medical setting. Hypertension. 2007 Jan;49(1):62-8. Epub 2006 Oct 30. — View Citation

Chrubasik S, Droste C, Glimm E, Black A. Comparison of different methods of blood pressure measurements. Blood Press Monit. 2007 Jun;12(3):157-66. — View Citation

ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 Practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2013 Oct;31(10):1925-38. doi: 10.1097/HJH.0b013e328364ca4c. — View Citation

Gaborieau V, Delarche N, Gosse P. Ambulatory blood pressure monitoring versus self-measurement of blood pressure at home: correlation with target organ damage. J Hypertens. 2008 Oct;26(10):1919-27. doi: 10.1097/HJH.0b013e32830c4368. — View Citation

Gorostidi M, Banegas JR, de la Sierra A, Vinyoles E, Segura J, Ruilope LM. Ambulatory blood pressure monitoring in daily clinical practice - the Spanish ABPM Registry experience. Eur J Clin Invest. 2016 Jan;46(1):92-8. doi: 10.1111/eci.12565. Epub 2015 Dec 23. Review. — View Citation

Huckvale C, Car J, Akiyama M, Jaafar S, Khoja T, Bin Khalid A, Sheikh A, Majeed A. Information technology for patient safety. Qual Saf Health Care. 2010 Aug;19 Suppl 2:i25-33. doi: 10.1136/qshc.2009.038497. — View Citation

Krause T, Lovibond K, Caulfield M, McCormack T, Williams B; Guideline Development Group. Management of hypertension: summary of NICE guidance. BMJ. 2011 Aug 25;343:d4891. doi: 10.1136/bmj.d4891. — View Citation

Little P, Barnett J, Barnsley L, Marjoram J, Fitzgerald-Barron A, Mant D. Comparison of agreement between different measures of blood pressure in primary care and daytime ambulatory blood pressure. BMJ. 2002 Aug 3;325(7358):254. — View Citation

Mas-Heredia M, Molés-Moliner E, González-de Paz L, Kostov B, Ortiz-Molina J, Mauri-Vázquez V, Menacho-Pascual I, Cararach-Salami D, Sierra-Benito C, Sisó-Almirall A. Validity and applicability of a new recording method for hypertension. Rev Esp Cardiol (Engl Ed). 2014 Sep;67(9):717-23. doi: 10.1016/j.rec.2013.12.017. Epub 2014 Apr 30. — View Citation

Mutlu S, Sari O, Arslan E, Aydogan U, Doganer YC, Koc B. Comparison of ambulatory blood pressure measurement with home, office and pharmacy measurements: is arterial blood pressure measured at pharmacy reliable? J Eval Clin Pract. 2016 Feb;22(1):40-45. doi: 10.1111/jep.12424. Epub 2015 Aug 24. — View Citation

Piper MA, Evans CV, Burda BU, Margolis KL, O'Connor E, Whitlock EP. Diagnostic and predictive accuracy of blood pressure screening methods with consideration of rescreening intervals: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2015 Feb 3;162(3):192-204. doi: 10.7326/M14-1539. Review. — View Citation

Sicras-Mainar A, Navarro-Artieda R. [Cost of arterial hypertension according to levels of morbidity in primary care setting]. Med Clin (Barc). 2009 Sep 5;133(8):290-5. doi: 10.1016/j.medcli.2009.05.017. Epub 2009 Jul 10. Spanish. — View Citation

Siu AL; U.S. Preventive Services Task Force. Screening for high blood pressure in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015 Nov 17;163(10):778-86. doi: 10.7326/M15-2223. Epub 2015 Oct 13. — View Citation

Turner JR, Viera AJ, Shimbo D. Ambulatory blood pressure monitoring in clinical practice: a review. Am J Med. 2015 Jan;128(1):14-20. doi: 10.1016/j.amjmed.2014.07.021. Epub 2014 Aug 12. Review. — View Citation

van der Wel MC, Buunk IE, van Weel C, Thien TA, Bakx JC. A novel approach to office blood pressure measurement: 30-minute office blood pressure vs daytime ambulatory blood pressure. Ann Fam Med. 2011 Mar-Apr;9(2):128-35. doi: 10.1370/afm.1211. — View Citation

Viera AJ, Hinderliter AL, Kshirsagar AV, Fine J, Dominik R. Reproducibility of masked hypertension in adults with untreated borderline office blood pressure: comparison of ambulatory and home monitoring. Am J Hypertens. 2010 Nov;23(11):1190-7. doi: 10.1038/ajh.2010.158. Epub 2010 Jul 29. — View Citation

Yang Q, Cogswell ME, Flanders WD, Hong Y, Zhang Z, Loustalot F, Gillespie C, Merritt R, Hu FB. Trends in cardiovascular health metrics and associations with all-cause and CVD mortality among US adults. JAMA. 2012 Mar 28;307(12):1273-83. doi: 10.1001/jama.2012.339. Epub 2012 Mar 16. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-hour blood pressure monitoring	Blood pressure measurements obtained by 1-hour blood pressure monitoring	Assessed at 1 study visit (1 hour)
Primary	24-hour ambulatory blood pressure monitoring	Blood pressure measurements obtained by 24-hour ambulatory blood pressure monitoring	Assessed at 1 day
Primary	Office blood pressure measurement	Blood pressure measurements obtained by office blood pressure measurement	Assessed at 3 study visits in two weeks
Primary	Home blood pressure monitoring	Blood pressure measurements obtained by home blood pressure monitoring	Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven