Carotid-Femoral, Oscillometric and Estimated Pulse Wave Velocity

NCT06836622 | Enrolling By Invitation DMC

• 1 other identifier: cfPWV, brPWV and ePWV
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

What is the purpose of this research? This research aims to compare three different methods of measuring pulse wave velocity, which is the main parameter used for assessing arterial stiffness. This parameter is as important as blood pressure in predicting future cardiovascular risk. The investigators intend to compare carotid-femoral pulse wave velocity, which is the gold standard for measuring arterial stiffness, with brachial pulse wave velocity measured using a device similar to a blood pressure monitor and a mathematical formula validated in a large European population. Who is eligible for this survey? Anyone aged 18 or older who has been invited may participate, provided they sign an informed consent form. Where will the field research be conducted? The research will be conducted at a health center specializing in the treatment of hypertension. This center is a reference for outpatient blood pressure monitoring in the city of Uberaba (MG), Brazil. Which procedures will be performed by research participants? All participants who consent will answer some questions about their demographic and health information. A trained nurse will measure their weight, height, and blood pressure after a 5-minute rest, and then measure carotid-femoral pulse wave velocity. The participant will lie down on a bed and the nurse will place a sensor on the middle of their neck and the groin. The device will automatically deliver the parameters. At least three measurements are required for each participant. Measurements normally take between 10 and 15 minutes. Then, participants will wear a device to record blood pressure and pulse wave velocity for 24 hours. The nurse will fit the cuff around the participant's arm and attach the monitoring device to a belt around their waist. The device will take measurements every 20 to 30 minutes. 24 hours later, the participant must return to the research venue to have the equipment removed. What are the risks and adverse events of the procedures? There are no known risks or adverse events (AEs) associated with carotid-femoral pulse wave velocity measurements. The risks of this research are minimal, limited to discomfort during the AMBP recording, which occurs at a low frequency. However, excessive arm pain, allergic reactions, and edema may occur. To minimize these risks, a nurse will be available via telephone to aid all participants during the AMBP recordings.

Conditions

Hypertension; Arterial Stiffness; Pulse Wave Analysis; Pulse Wave Velocity

Keywords

Arterial stiffness; Hypertension; Pulse wave velocity

Outcome Measures

Primary Outcomes (1)

• Concordance correlation coefficient

  The concordance correlation coefficient evaluates the degree to which pairs of observations fall on the 45° line through the origin. The concordance correlation coefficient (ρc) contains a measurement of precision (ρ) and accuracy (Cb). * ρ is the Pearson correlation coefficient, which measures how far each observation deviates from the best-fit line, and is a measure of precision, and * Cb is a bias correction factor that measures how far the best-fit line deviates from the 45° line through the origin, and is a measure of accuracy.

  Through study completion, an average of 1 year.

Secondary Outcomes (1)

• Means

  Through study completion, an average of 1 year.

Study Arms (1)

Adults older than eighteen with elevated office BP, treated and untreated.

All participants were referred by a physician to perform ambulatory blood pressure monitoring (ABPM) to confirm a hypertension diagnosis or evaluate uncontrolled hypertension.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals older than 18 with a suspected hypertension diagnosis or under treatment who were referred to record twenty-four hours of ABPM either to confirm a hypertension diagnosis or evaluate uncontrolled hypertension. The participants will be selected in a specialized center in inner Brazil to diagnose and treat non-communicable diseases.

You may qualify if:

• \- Individuals older than 18 with an elevated office blood pressure :
• suspected hypertension diagnosis or
• uncontrolled hypertension under treatment

You may not qualify if:

• hour ABPM recordings presenting:
• less than 70% of the expected measurements or
• fewer than 20 valid awake or seven valid sleeping measurements or
• fewer than two valid daytime and one valid night-time measurement per hour

Sponsors & Collaborators

• Hospital de Base: lead

Study Sites (1)

CDC center

Uberaba, Minas Gerais, 38025-050, Brazil

Location

Related Publications (20)

• Silva MA, Oliveira AP, Queiroz AC, Spaziani AO, Fernandes LA, De Oliveira KA, Lopes VDS, Landim MP, Cosenso-Martin LN, Vilela-Martin JF. Correlation between estimated pulse wave velocity values from two equations in healthy and under cardiovascular risk populations. PLoS One. 2024 Apr 9;19(4):e0298405. doi: 10.1371/journal.pone.0298405. eCollection 2024.

  PMID: 38593112 BACKGROUND

• Stergiou GS, Palatini P, Parati G, O'Brien E, Januszewicz A, Lurbe E, Persu A, Mancia G, Kreutz R; European Society of Hypertension Council and the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. 2021 European Society of Hypertension practice guidelines for office and out-of-office blood pressure measurement. J Hypertens. 2021 Jul 1;39(7):1293-1302. doi: 10.1097/HJH.0000000000002843. No abstract available.

  PMID: 33710173 BACKGROUND

• Van Bortel LM, Laurent S, Boutouyrie P, Chowienczyk P, Cruickshank JK, De Backer T, Filipovsky J, Huybrechts S, Mattace-Raso FU, Protogerou AD, Schillaci G, Segers P, Vermeersch S, Weber T; Artery Society; European Society of Hypertension Working Group on Vascular Structure and Function; European Network for Noninvasive Investigation of Large Arteries. Expert consensus document on the measurement of aortic stiffness in daily practice using carotid-femoral pulse wave velocity. J Hypertens. 2012 Mar;30(3):445-8. doi: 10.1097/HJH.0b013e32834fa8b0.

  PMID: 22278144 BACKGROUND

• McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.

  PMID: 39210715 BACKGROUND

• Stamatelopoulos K, Georgiopoulos G, Baker KF, Tiseo G, Delialis D, Lazaridis C, Barbieri G, Masi S, Vlachogiannis NI, Sopova K, Mengozzi A, Ghiadoni L, Schim van der Loeff I, Hanrath AT, Ajdini B, Vlachopoulos C, Dimopoulos MA, Duncan CJA, Falcone M, Stellos K; Pisa COVID-19 Research Group; Newcastle COVID-19 Research Group. Estimated pulse wave velocity improves risk stratification for all-cause mortality in patients with COVID-19. Sci Rep. 2021 Oct 12;11(1):20239. doi: 10.1038/s41598-021-99050-0.

  PMID: 34642385 BACKGROUND

• Greve SV, Blicher MK, Kruger R, Sehestedt T, Gram-Kampmann E, Rasmussen S, Vishram JK, Boutouyrie P, Laurent S, Olsen MH. Estimated carotid-femoral pulse wave velocity has similar predictive value as measured carotid-femoral pulse wave velocity. J Hypertens. 2016 Jul;34(7):1279-89. doi: 10.1097/HJH.0000000000000935.

  PMID: 27088638 BACKGROUND

• Hametner B, Wassertheurer S, Mayer CC, Danninger K, Binder RK, Weber T. Aortic Pulse Wave Velocity Predicts Cardiovascular Events and Mortality in Patients Undergoing Coronary Angiography: A Comparison of Invasive Measurements and Noninvasive Estimates. Hypertension. 2021 Feb;77(2):571-581. doi: 10.1161/HYPERTENSIONAHA.120.15336. Epub 2021 Jan 4.

  PMID: 33390046 BACKGROUND

• Reference Values for Arterial Stiffness' Collaboration. Determinants of pulse wave velocity in healthy people and in the presence of cardiovascular risk factors: 'establishing normal and reference values'. Eur Heart J. 2010 Oct;31(19):2338-50. doi: 10.1093/eurheartj/ehq165. Epub 2010 Jun 7.

  PMID: 20530030 BACKGROUND

• Sarafidis PA, Loutradis C, Karpetas A, Tzanis G, Piperidou A, Koutroumpas G, Raptis V, Syrgkanis C, Liakopoulos V, Efstratiadis G, London G, Zoccali C. Ambulatory Pulse Wave Velocity Is a Stronger Predictor of Cardiovascular Events and All-Cause Mortality Than Office and Ambulatory Blood Pressure in Hemodialysis Patients. Hypertension. 2017 Jul;70(1):148-157. doi: 10.1161/HYPERTENSIONAHA.117.09023. Epub 2017 May 8.

  PMID: 28483919 BACKGROUND

• Baumann M, Wassertheurer S, Suttmann Y, Burkhardt K, Heemann U. Aortic pulse wave velocity predicts mortality in chronic kidney disease stages 2-4. J Hypertens. 2014 Apr;32(4):899-903. doi: 10.1097/HJH.0000000000000113.

  PMID: 24609217 BACKGROUND

• Salvi P, Scalise F, Rovina M, Moretti F, Salvi L, Grillo A, Gao L, Baldi C, Faini A, Furlanis G, Sorropago A, Millasseau SC, Sorropago G, Carretta R, Avolio AP, Parati G. Noninvasive Estimation of Aortic Stiffness Through Different Approaches. Hypertension. 2019 Jul;74(1):117-129. doi: 10.1161/HYPERTENSIONAHA.119.12853. Epub 2019 May 28.

  PMID: 31132954 BACKGROUND

• Spronck B, Terentes-Printzios D, Avolio AP, Boutouyrie P, Guala A, Jeroncic A, Laurent S, Barbosa ECD, Baulmann J, Chen CH, Chirinos JA, Daskalopoulou SS, Hughes AD, Mahmud A, Mayer CC, Park JB, Pierce GL, Schutte AE, Urbina EM, Wilkinson IB, Segers P, Sharman JE, Tan I, Vlachopoulos C, Weber T, Bianchini E, Bruno RM; Association for Research into Arterial Structure and Physiology (ARTERY), the European Society of Hypertension Working Group on Large Arteries, European Cooperation in Science and Technology (COST) Action VascAgeNet, North American Artery Society, ARTERY LATAM, Pulse of Asia, and Society for Arterial Stiffness-Germany-Austria-Switzerland (DeGAG). 2024 Recommendations for Validation of Noninvasive Arterial Pulse Wave Velocity Measurement Devices. Hypertension. 2024 Jan;81(1):183-192. doi: 10.1161/HYPERTENSIONAHA.123.21618. Epub 2023 Nov 17.

  PMID: 37975229 BACKGROUND

• Segers P, Rietzschel ER, Chirinos JA. How to Measure Arterial Stiffness in Humans. Arterioscler Thromb Vasc Biol. 2020 May;40(5):1034-1043. doi: 10.1161/ATVBAHA.119.313132. Epub 2019 Dec 26.

  PMID: 31875700 BACKGROUND

• Townsend RR, Wilkinson IB, Schiffrin EL, Avolio AP, Chirinos JA, Cockcroft JR, Heffernan KS, Lakatta EG, McEniery CM, Mitchell GF, Najjar SS, Nichols WW, Urbina EM, Weber T; American Heart Association Council on Hypertension. Recommendations for Improving and Standardizing Vascular Research on Arterial Stiffness: A Scientific Statement From the American Heart Association. Hypertension. 2015 Sep;66(3):698-722. doi: 10.1161/HYP.0000000000000033. Epub 2015 Jul 9. No abstract available.

  PMID: 26160955 BACKGROUND

• Safar ME, Toto-Moukouo JJ, Bouthier JA, Asmar RE, Levenson JA, Simon AC, London GM. Arterial dynamics, cardiac hypertrophy, and antihypertensive treatment. Circulation. 1987 Jan;75(1 Pt 2):I156-61.

  PMID: 2947747 BACKGROUND

• Ben-Shlomo Y, Spears M, Boustred C, May M, Anderson SG, Benjamin EJ, Boutouyrie P, Cameron J, Chen CH, Cruickshank JK, Hwang SJ, Lakatta EG, Laurent S, Maldonado J, Mitchell GF, Najjar SS, Newman AB, Ohishi M, Pannier B, Pereira T, Vasan RS, Shokawa T, Sutton-Tyrell K, Verbeke F, Wang KL, Webb DJ, Willum Hansen T, Zoungas S, McEniery CM, Cockcroft JR, Wilkinson IB. Aortic pulse wave velocity improves cardiovascular event prediction: an individual participant meta-analysis of prospective observational data from 17,635 subjects. J Am Coll Cardiol. 2014 Feb 25;63(7):636-646. doi: 10.1016/j.jacc.2013.09.063. Epub 2013 Nov 13.

  PMID: 24239664 BACKGROUND

• Safar ME, Asmar R, Benetos A, Blacher J, Boutouyrie P, Lacolley P, Laurent S, London G, Pannier B, Protogerou A, Regnault V; French Study Group on Arterial Stiffness. Interaction Between Hypertension and Arterial Stiffness. Hypertension. 2018 Oct;72(4):796-805. doi: 10.1161/HYPERTENSIONAHA.118.11212. No abstract available.

  PMID: 30354723 BACKGROUND

• Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8.

  PMID: 12493255 BACKGROUND

• Franklin SS, Gustin W 4th, Wong ND, Larson MG, Weber MA, Kannel WB, Levy D. Hemodynamic patterns of age-related changes in blood pressure. The Framingham Heart Study. Circulation. 1997 Jul 1;96(1):308-15. doi: 10.1161/01.cir.96.1.308.

  PMID: 9236450 BACKGROUND

• Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Nat Rev Nephrol. 2020 Apr;16(4):223-237. doi: 10.1038/s41581-019-0244-2. Epub 2020 Feb 5.

  PMID: 32024986 BACKGROUND

Related Links

• Plataforma Brasil CAAE number : 57703722.7.0000.5415

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 20, 2025
• Study Start: September 1, 2022
• Primary Completion: February 1, 2026
• Study Completion: March 2, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)