NCT03154203

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

May 7, 2017

Last Update Submit

August 16, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular events

    4 years

  • cardiovascular and all-cause mortality

    4 years

Interventions

No intervention in this study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Cardiology, Professor of Tongji University, FACC

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 16, 2017

Study Start

June 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2021

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations