Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS

NCT01515878 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2012-07-06

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

Hemocontrol

Blood Volume Tracking system using biofeedback

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • 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

  • Antonio Santoro, Pf · AOSP, Bologna Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Canada
  • France
  • Italy

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01515878 on ClinicalTrials.gov