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

NCT ID: NCT03154203

Last Updated: 2017-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention in this study

No intervention in this study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ya-Wei Xu

Director of Department of Cardiology, Professor of Tongji University, FACC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shikai Yu, MD

Role: primary

+86 18801790211

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 26304958 (View on PubMed)

Zhang 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.

Reference Type RESULT
PMID: 25391758 (View on PubMed)

Protogerou 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.

Reference Type RESULT
PMID: 24999798 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAFAR-CN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Contactless Radar Blood Pressure Validation
NCT06035107 NOT_YET_RECRUITING
China Rural Hypertension Control Project
NCT03527719 ACTIVE_NOT_RECRUITING NA
Prognostic Model of Hypertension
NCT06160921 RECRUITING