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

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03154203
Collaborator
(none)
3,000
1
49
61.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention in this study

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
Jun 30, 2018
Anticipated Study Completion Date :
Jun 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Cardiovascular events [4 years]

  2. cardiovascular and all-cause mortality [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Tenth People's Hospital Shanghai Shanghai China 200072

Sponsors and Collaborators

  • Shanghai 10th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ya-Wei Xu, Director of Department of Cardiology, Professor of Tongji University, FACC, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT03154203
Other Study ID Numbers:
  • SAFAR-CN
First Posted:
May 16, 2017
Last Update Posted:
Aug 21, 2017
Last Verified:
Aug 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 21, 2017