Sponsor study identifier
NIH
interventional
396
3 countries
3
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and by reduced incidence of intradialytic hypotensive episodes
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 19, 2012
Actual (reported)January 24, 2012
Actual (reported)February 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cardiovascular events
The primary objective will be assessed by the incidence rate of Fatal and not fatal cardiovascular events
36 months
Cardiovascular morbidity
36 months
Blood pressure control
36 months
Quality of life and dialysis tolerance evaluated with questionnaire.
36 months
Dry weight management
36 months
Dialysis using the BVT monitor biofeedback called Hemocontrol
Conventional dialysis without blood volume tracking or similar therapies
Blood Volume Tracking system using biofeedback
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Health Regional hospital
Calgary, Canada
Hopital Tenon, APHP
Paris, 75970, France
Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Jennifer Mac Rae, MD
Calgary hospital, Canada
Hafedh Fessi, MD
APHP Tenon, Paris France
Juan Buades, MD
Majorca hospital, Spain
Helena Mancini, MD
AOSP, Bologna Italy
First Submitted
January 19, 2012
First Posted
January 24, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Contact the study team to confirm eligibility.
Antonio Santoro, Pf
AOSP, Bologna Italy
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 6, 2012
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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