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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Unknown; Phase 4

Conditions: Kidney Failure Chronic; Cardiovascular Diseases

Treatments: Device: Hemocontrol

Study type: Interventional

Funder types: Other

Identifiers

NCT01515878

2019

Details and patient eligibility

About

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

Enrollment: 396 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age more than 65 years old
2. Arterial Hypertension: predialysis SBP >140 mmHg and/or DBP >90 mmHg in at least 50% over the previous month dialysis sessions or receiving at least one antihypertensive pharmacological drug including diuretics, disregarded blood pressure value
3. On a three times per week hemodialysis schedule
4. Time on hemodialysis less than 6 months
5. Able to measure their blood pressure at home (by themselves or with the aid of the care giver)
6. Signed informed consent

Exclusion criteria

1. Active neoplastic disease
2. Mental illness
3. Pregnancy
4. Single needle treatment
5. Inability, as judged by the investigator, to follow or understand the protocol instructions
6. Blood flow rate less than 200 mL/min
7. Patients who at the time of recruitment need clinical indication for special renal replacement therapies and/or on treatment with one of the following modalities: HDF or similar diffusive-convective therapies, treatment time >5h, blood temperature control, isolated UF profiling of Na/UFR
8. Patients with a life expectancy shorter than 6 months
9. Patients in a list for transplant within the next 6 months
10. Predialysis Hemoglobin level greater than 13.5 g/dl
11. History of major cardiovascular events during run in period

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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396 participants in 2 patient groups

Dialysis with BVT

Experimental group

Description:

Dialysis using the BVT monitor biofeedback called Hemocontrol

Treatment:

Device: Hemocontrol

Conventional dialysis

No Intervention group

Description:

Conventional dialysis without blood volume tracking or similar therapies