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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 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

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 more

HERACLES 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
202 Previous Clinical Trials
376,190 Total Patients Enrolled
Jennifer Mac Rae, MDStudy ChairCalgary hospital, Canada
Hafedh Fessi, MDStudy ChairAPHP Tenon, Paris France

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS
Antonio Santoro 2012. "Hemocontrol's Effectiveness on the Reduction of Cardiovascular Long-term EventS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01515878.
All > Cardiovascular
~30 spots leftby Apr 2025
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