Blood PressureSAFAR-ChinaNCT03154203
Non-Invasive Aortic Ambulatory Blood Pressure Monitoring for The Detection of Target Organ Damage in The Chinese Population
An observational study of Blood Pressure and Cardiovascular Risk Factor, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
This study is a sub-investigation of SAFAR study. Consecutive patients with established hypertension (treated or untreated with antihypertensive drugs) or with suspected hypertension are recruited and their 24-hour brachial and aortic blood pressures, cardiovascular risk factors and target organ damage are assessed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Cardiovascular Risk Factor, Target Organ Damage
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 30 Jun 2021
- Phase
- Observational
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients with established hypertension (treated or untreated with antihypertensive drugs) or with suspected hypertension
Who may be able to join
- patients with established hypertension (treated or untreated with antihypertensive drugs) or with suspected hypertension
Who cannot join
- Age<18 years old
- the absence of sinus rhythm during BP monitoring
- any modification in cardiovascular disease medication in the past month
- inability to provide informed consent or unwillingness/inability to adhere to study protocol
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Shikai Yu, MD, +86 18801790211, shikaiyu@yahoo.com
About this study
Official title: The Study of Non-Invasive Aortic Ambulatory Blood Pressure Monitoring for The Detection of Target Organ Damage in The Population Of Chinese Patient (SAFAR-China)
This study is a sub-investigation of SAFAR study. Consecutive patients with established hypertension (treated or untreated with antihypertensive drugs) or with suspected hypertension are recruited and their 24-hour brachial and aortic blood pressures, cardiovascular risk factors and target organ damage are assessed. And the participants' target organ damage, cardiovascular events, cardiovascular and overall mortality will be followed four years later.
Read the detailed description
SAFAR study is an ongoing perspective study which is performed in Greek. We have been participated this study and now we are going to expand this study in Chinese population.
In Shanghai Tenth People's Hospital, we recruit consecutive patients who meet the including criteria. And their medical and family history are obtained with standardized structured questionnaire including information about smoking and drinking and exercise habits, history of diabetes mellitus, cardio-cerebrovascular disease, renal disease and peripheral arterial disease, use of antihypertensive, lipid-regulating and hypoglycemic drugs. Their biochemical examinations of venous blood and urine were measured after an overnight fast.
For the 24-hour brachial and aortic ambulatory blood pressure monitoring of each patient, we use the Mobil-O-Graph NG apparatus (IEM, Stolberg, Germany), which is well validated and now commercially available.
All participants underwent carotid and cardiac ultrasonography by a validated ultrasound system (Mylab 30 CV machine, ESAOTE SPA, Genoa, Italy). The parameters of cardiac function and structure and the parameters of carotid arteries are assessed according to the ASE recommendation. Further, we use these parameters to estimate the damage of heart and carotid artery including left ventricular mass index (LVMI), carotid left ventricular diastolic function (LVDD), intima-media thickness (CIMT) and cross-sectional area(CCSA).
Four years later, the above measurements will be performed again and the corresponding data of events and mortality will be collected.
- Conditions
- Blood Pressure, Cardiovascular Risk Factor, Target Organ Damage, Cardiovascular Events, Cardiovascular Mortality, Overall Mortality
- Being tested
- No intervention in this study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in this studyOther
No intervention in this study
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Measured: 4 years
cardiovascular and all-cause mortality
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jun 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154203
- Sponsor's protocol ID
- SAFAR-CN
- Acronym
- SAFAR-China
- Status last verified
- Aug 2017
- First submitted
- 7 May 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aissopou EK, Argyris AA, Nasothimiou EG, Konstantonis GD, Tampakis K, Tentolouris N, Papathanassiou M, Theodossiadis PG, Papaioannou TG, Stehouwer CD, Sfikakis PP, Protogerou AD. Ambulatory Aortic Stiffness Is Associated With Narrow Retinal Arteriolar Caliber in Hypertensives: The SAFAR Study. Am J Hypertens. 2016 May;29(5):626-33. doi: 10.1093/ajh/hpv145. Epub 2015 Aug 24.
PubMed 26304958Zhang Y, Kollias G, Argyris AA, Papaioannou TG, Tountas C, Konstantonis GD, Achimastos A, Blacher J, Safar ME, Sfikakis PP, Protogerou AD. Association of left ventricular diastolic dysfunction with 24-h aortic ambulatory blood pressure: the SAFAR study. J Hum Hypertens. 2015 Jul;29(7):442-8. doi: 10.1038/jhh.2014.101. Epub 2014 Nov 13.
PubMed 25391758Protogerou AD, Argyris AA, Papaioannou TG, Kollias GE, Konstantonis GD, Nasothimiou E, Achimastos A, Blacher J, Safar ME, Sfikakis PP. Left-ventricular hypertrophy is associated better with 24-h aortic pressure than 24-h brachial pressure in hypertensive patients: the SAFAR study. J Hypertens. 2014 Sep;32(9):1805-14. doi: 10.1097/HJH.0000000000000263.
PubMed 24999798