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Biofeedback Device
Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS (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
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal 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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cardiovascular events
Secondary study objectives
Blood pressure control
Cardiovascular morbidity
Dry weight management
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Who is running the clinical trial?
IRCCS Azienda Ospedaliero-Universitaria di BolognaLead Sponsor
258 Previous Clinical Trials
403,777 Total Patients Enrolled
Jennifer Mac Rae, MDStudy ChairCalgary hospital, Canada
Hafedh Fessi, MDStudy ChairAPHP Tenon, Paris France
Juan Buades, MDStudy ChairMajorca hospital, Spain
Helena Mancini, MDStudy ChairAOSP, Bologna Italy
Antonio Santoro, PfStudy ChairAOSP, Bologna Italy