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Biofeedback Device
Dialysis with BVT for Cardiovascular Disease (HERACLES Trial)
Phase 4
Waitlist Available
Research Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
HERACLES Trial 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
Eligible Conditions
- Cardiovascular Disease
- Chronic Kidney Disease
HERACLES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiovascular events
Secondary outcome measures
Blood pressure control
Cardiovascular morbidity
Dry weight management
+1 moreHERACLES Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dialysis with BVTExperimental Treatment1 Intervention
Dialysis using the BVT monitor biofeedback called Hemocontrol
Group II: Conventional dialysisActive Control1 Intervention
Conventional dialysis without blood volume tracking or similar therapies
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Who is running the clinical trial?
IRCCS Azienda Ospedaliero-Universitaria di BolognaLead Sponsor
202 Previous Clinical Trials
376,190 Total Patients Enrolled
Jennifer Mac Rae, MDStudy ChairCalgary hospital, Canada
Hafedh Fessi, MDStudy ChairAPHP Tenon, Paris France
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