HypertensionCF-O-E-PWVNCT06836622
Carotid-Femoral, Oscillometric and Estimated Pulse Wave Velocity
An observational study of Hypertension and Arterial Stiffness, run by Hospital de Base at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Arterial Stiffness, Pulse Wave Analysis
- How many people
- 350 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Individuals older than 18 with an elevated office blood pressure :
- suspected hypertension diagnosis or
- uncontrolled hypertension under treatment
Who cannot join
- 24-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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Correlation Between the Values of Carotid-Femoral, Oscillometric and Estimated Pulse Wave Velocity
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.
Read more
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. Patients enrolled in the study will also be included in the Hypertension Center of the Faculdade de Medicina de São José do Rio Preto (FAMERP).
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.
Read the detailed description
Hypertension is one of the leading causes of cardiovascular morbidity and mortality worldwide and is strongly associated with myocardial infarction, stroke, heart failure, and premature death. In addition to elevated blood pressure levels, vascular alterations such as arterial stiffness have emerged as important markers of cardiovascular risk. Carotid-femoral pulse wave velocity (cfPWV) is currently considered the gold standard non-invasive method for the assessment of aortic stiffness and has consistently demonstrated independent associations with cardiovascular events and mortality.
Over recent decades, alternative methods for pulse wave velocity (PWV) assessment have been developed. Oscillometric brachial cuff-based devices can estimate PWV through proprietary algorithms derived from blood pressure waveform analysis. The Mobil-O-Graph system is one of the most widely studied oscillometric devices and has shown associations between brachial PWV (brPWV) and cardiovascular outcomes in different clinical settings.
In parallel, estimated pulse wave velocity (ePWV), calculated using mathematical equations based on age and mean blood pressure, has emerged as a simple surrogate marker of arterial stiffness. Previous studies demonstrated that ePWV predicts cardiovascular events and mortality independently of traditional cardiovascular risk scores and even independently of measured cfPWV in some populations.
Although both oscillometric PWV and equation-derived PWV have shown prognostic value, uncertainties remain regarding the degree to which these methods reflect true aortic stiffness when compared with directly measured carotid-femoral PWV. Since oscillometric algorithms and ePWV equations are strongly influenced by age and blood pressure, further studies are necessary to better understand their relationship with the reference standard method.
The present study aims to evaluate the agreement and association between carotid-femoral pulse wave velocity, oscillometric brachial pulse wave velocity, and estimated pulse wave velocity in adults undergoing ambulatory blood pressure monitoring as part of routine clinical evaluation.
This is an observational cross-sectional study conducted in a specialized cardiovascular center in Brazil. The study population includes adults referred for ambulatory blood pressure monitoring (ABPM) for investigation or characterization of blood pressure abnormalities.
Participants undergo office blood pressure measurement, anthropometric assessment, 24-hour ABPM, carotid-femoral pulse wave velocity evaluation, and oscillometric brachial pulse wave analysis under standardized conditions.
Arterial stiffness is assessed using the Complior Analyze device according to current recommendations for non-invasive evaluation of aortic stiffness. Ambulatory blood pressure monitoring and oscillometric brachial PWV measurements are performed using a validated oscillometric device programmed for daytime and nighttime recordings according to guideline recommendations.
Estimated pulse wave velocity is calculated using validated equations derived from the Reference Values for Arterial Stiffness Collaboration based on age and mean blood pressure values.
All participants also underwent routine laboratory evaluation requested by the attending physician at the time of referral for ambulatory blood pressure monitoring. Blood samples collected under fasting conditions included measurements of total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Laboratory data obtained from routine clinical care were collected and analyzed for research purposes as part of the present observational study.
The primary objective of the study is to evaluate the agreement between cfPWV, brPWV, and ePWV. Statistical analyses include correlation and agreement analyses between pulse wave velocity methods using standardized statistical approaches.
The study is observational and non-interventional. All procedures are performed within the context of routine clinical care, and all participants provided written informed consent prior to inclusion in the study.
- Keywords
- Arterial stiffness, Hypertension, Pulse wave velocity
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Means
Means of cf-PWV, br-PWV, and e-PWV. Arithmetic mean: the arithmetic mean x ¯ x¯ is the sum of all observations divided by the number of observations n.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jul 2026 (estimated)
- Primary completion6 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOSE FERNANDO VILELA-MARTIN, Hospital de Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836622
- Sponsor's protocol ID
- cfPWV, brPWV and ePWV
- Acronym
- CF-O-E-PWV
- Status last verified
- May 2026
- First submitted
- 6 Feb 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38593112Stergiou 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.
PubMed 33710173Van 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.
PubMed 22278144McEvoy 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.
PubMed 39210715Stamatelopoulos 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.
PubMed 34642385Greve 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.
PubMed 27088638Hametner 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.
PubMed 33390046Reference 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.
PubMed 20530030Sarafidis 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.
PubMed 28483919Baumann 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.
PubMed 24609217Salvi 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.
PubMed 31132954Spronck 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.
PubMed 37975229Segers 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.
PubMed 31875700Townsend 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.
PubMed 26160955Safar 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.
PubMed 2947747
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Values of Carotid-Femoral, Oscillometric and Estimated Pulse Wave Velocity
- ClinicalTrials.gov ID
- NCT06836622
- Acronym / sponsor ID
- CF-O-E-PWV / cfPWV, brPWV and ePWV
- Keywords
- Arterial stiffness, Hypertension, Pulse wave velocity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Patients enrolled in the study will also be included in the Hypertension Center of the Faculdade de Medicina de São José do Rio Preto (FAMERP).
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.
Detailed description
Hypertension is one of the leading causes of cardiovascular morbidity and mortality worldwide and is strongly associated with myocardial infarction, stroke, heart failure, and premature death. In addition to elevated blood pressure levels, vascular alterations such as arterial stiffness have emerged as important markers of cardiovascular risk. Carotid-femoral pulse wave velocity (cfPWV) is currently considered the gold standard non-invasive method for the assessment of aortic stiffness and has consistently demonstrated independent associations with cardiovascular events and mortality.
Over recent decades, alternative methods for pulse wave velocity (PWV) assessment have been developed. Oscillometric brachial cuff-based devices can estimate PWV through proprietary algorithms derived from blood pressure waveform analysis. The Mobil-O-Graph system is one of the most widely studied oscillometric devices and has shown associations between brachial PWV (brPWV) and cardiovascular outcomes in different clinical settings.
In parallel, estimated pulse wave velocity (ePWV), calculated using mathematical equations based on age and mean blood pressure, has emerged as a simple surrogate marker of arterial stiffness. Previous studies demonstrated that ePWV predicts cardiovascular events and mortality independently of traditional cardiovascular risk scores and even independently of measured cfPWV in some populations.
Although both oscillometric PWV and equation-derived PWV have shown prognostic value, uncertainties remain regarding the degree to which these methods reflect true aortic stiffness when compared with directly measured carotid-femoral PWV. Since oscillometric algorithms and ePWV equations are strongly influenced by age and blood pressure, further studies are necessary to better understand their relationship with the reference standard method.
The present study aims to evaluate the agreement and association between carotid-femoral pulse wave velocity, oscillometric brachial pulse wave velocity, and estimated pulse wave velocity in adults undergoing ambulatory blood pressure monitoring as part of routine clinical evaluation.
This is an observational cross-sectional study conducted in a specialized cardiovascular center in Brazil. The study population includes adults referred for ambulatory blood pressure monitoring (ABPM) for investigation or characterization of blood pressure abnormalities.
Participants undergo office blood pressure measurement, anthropometric assessment, 24-hour ABPM, carotid-femoral pulse wave velocity evaluation, and oscillometric brachial pulse wave analysis under standardized conditions.
Arterial stiffness is assessed using the Complior Analyze device according to current recommendations for non-invasive evaluation of aortic stiffness. Ambulatory blood pressure monitoring and oscillometric brachial PWV measurements are performed using a validated oscillometric device programmed for daytime and nighttime recordings according to guideline recommendations.
Estimated pulse wave velocity is calculated using validated equations derived from the Reference Values for Arterial Stiffness Collaboration based on age and mean blood pressure values.
All participants also underwent routine laboratory evaluation requested by the attending physician at the time of referral for ambulatory blood pressure monitoring. Blood samples collected under fasting conditions included measurements of total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Laboratory data obtained from routine clinical care were collected and analyzed for research purposes as part of the present observational study.
The primary objective of the study is to evaluate the agreement between cfPWV, brPWV, and ePWV. Statistical analyses include correlation and agreement analyses between pulse wave velocity methods using standardized statistical approaches.
The study is observational and non-interventional. All procedures are performed within the context of routine clinical care, and all participants provided written informed consent prior to inclusion in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Individuals older than 18 with an elevated office blood pressure :
- suspected hypertension diagnosis or
- uncontrolled hypertension under treatment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance correlation coefficient
Time frame: Through study completion, an average of 1 year.
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.
1 secondary outcome
Means
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Results publication: PubMed 38593112Silva 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.
- Results publication: PubMed 33710173Stergiou 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.
- Results publication: PubMed 22278144Van 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.
- Results publication: PubMed 39210715McEvoy 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.
- Results publication: PubMed 34642385Stamatelopoulos 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.
- Results publication: PubMed 27088638Greve 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.
- Results publication: PubMed 33390046Hametner 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.
- Results publication: PubMed 20530030Reference 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.
- Results publication: PubMed 28483919Sarafidis 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.
- Results publication: PubMed 24609217Baumann 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.
- Results publication: PubMed 31132954Salvi 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.
- Results publication: PubMed 37975229Spronck 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.
- Plataforma Brasil CAAE number : 57703722.7.0000.5415Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Arterial Stiffness, run by Hospital de Base at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARCO A VIEIRA DA SILVA, Master (+55 34 984017474, marcovieiravs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance correlation coefficient (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836622, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.