Skip to content

Non-Invasive Aortic Ambulatory Blood Pressure Monitoring for The Detection of Target Organ Damage in The Chinese Population

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03154203
Acronym
SAFAR-China
Enrollment
3000
Registered
2017-05-16
Start date
2017-06-01
Completion date
2021-06-30
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Cardiovascular Events, Cardiovascular Mortality, Cardiovascular Risk Factor, Overall Mortality, Target Organ Damage

Brief 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. And the participants' target organ damage, cardiovascular events, cardiovascular and overall mortality will be followed four years later.

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.

Interventions

No intervention in this study

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* patients with established hypertension (treated or untreated with antihypertensive drugs) or with suspected hypertension

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Cardiovascular events4 years
cardiovascular and all-cause mortality4 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026